Expanded Reimbursement Measures Mean Greater Access

Overview
More Patients & Providers Can Now Access Non-Opioid Pain Management Options Like EXPAREL
Expanded Reimbursement Measures Include1-3:
- Separate payment in ASCs since 2019
- Medicare reimbursement at ASP+6% under the NOPAIN Act (effective 1/1/25), expanding EXPAREL coverage for millions of patients
ASP+6% = reimbursement of 106% of the average sales price
ASC, ambulatory surgery center; ASP, average selling price; NOPAIN, Non-Opioids Prevent Addiction in the Nation.
Additional Initiatives Further Improve Access to EXPAREL
- Partnerships with major GPOs, IDNs and ASCs to ensure systems have access to contract pricing, which will reduce overall net costs
- Access for eligible 340B facilities to discounted products for indigent patients
- Product-specific codes for streamlined reimbursement and billing, increasing recognition and coverage by commercial payers4
- J0666 for procedures performed in outpatient procedures
- D9613 for dental procedures
ASC, ambulatory surgery center; CMS, Centers for Medicare & Medicaid Services; GPO, Group Purchasing Organization;
IDN, integrated delivery network.


Reimbursement
Navigating Reimbursement: Codes for EXPAREL
EXPAREL is Reimbursed for Procedures Performed in Outpatient Procedures Using the Code J0666 and for Dental Procedures Using Code D9613*
J0666: For Procedures Performed in Outpatient Settings4
Effective January 1, 2025, the CMS has granted a unique, product-specific billing code, or J-code, J0666, for EXPAREL used in outpatient settings.* To learn more, click here.
As of April 1, 2025
J0666 1 mg = 1 unit
Allowed Medicare amount for reimbursement†: $1.421/mg
$377.99‡
266 mg (20 mL) dose
$188.99‡
133 mg (10 mL) dose
D9613:
For Dental Procedures
D9613 is defined as the infiltration of a sustained-release therapeutic drug, per quadrant, which allows for EXPAREL reimbursement in oral surgery procedures.

For more information, contact our dedicated reimbursement specialists at reimbursement@pacira.com or call our Reimbursement Helpline at 1-855-793-9727.
*For dates of service prior to January 1, 2025, Medicare reimbursement is available in ASCs when billing with C9290. For commercial or Medicare Advantage plans, please confirm with the individual payer
†As of April 1, 2025; pricing subject to CMS Medicare updates. Pacira cannot guarantee reimbursement
‡The allowed amount for reimbursement is based on the full dose being used for the surgical procedure
ASC, ambulatory surgery center; CMS, Centers for Medicare & Medicaid Services.
NOPAIN Act
The NOPAIN Act Mandates That Medicare Reimburse for Qualified Non-Opioids, Like EXPAREL, Across All Outpatient Settings5,6
The bipartisan and bicameral NOPAIN Act was designed to increase patient and provider access to non-opioid pain management options by removing the barriers associated with reimbursement for the Medicare population. With Congress passing the NOPAIN Act, you can now provide branded non-opioids—like EXPAREL—to your Medicare patients for improved management of postsurgical pain while minimizing financial barriers.2,5,7
Congress has mandated that Medicare provide expanded reimbursement for qualifying non-opioid options.5,6
The NOPAIN Act will expand access across outpatient procedures.5
The NOPAIN Act will cover reimbursement for drugs and devices that have demonstrated the ability to reduce or avoid intraoperative or postoperative opioid use, including EXPAREL.5,7,8
The Act was designed to take steps to stop future addiction before it can begin by ensuring that Medicare patients have access to non-opioids while dealing with postsurgical pain.2,5
NOPAIN, Non-Opioids Prevent Addiction in the Nation.
ASP+6% Reimbursement Calculation for EXPAREL, Q1 20259
133 mg vial | |
---|---|
EXPAREL ASP Q1 2025 $1.363/mg | $181.279/vial |
CMS payment rate (ASP+6%) $1.45/mg | $192.85 |
Medicare pays 80% - 2% sequestration | $154.28 - $3.09 = $151.19 |
Patient pays 20% coinsurance | $38.57 |
Total provider Medicare reimbursement | $189.76 |
This represents the ASP+6% payment rate, less sequestration for EXPAREL
($192.85 × 0.8 = $154.28
$154.28 × 0.02 = $3.09)
ASP, average selling price; CMS, Centers for Medicare & Medicaid Services.
ASP+6% = reimbursement of 106% of the average sales price
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Clinical & Economic Outcomes
EXPAREL Is a Cost-Effective Option for Postsurgical Pain Management in the Outpatient Settings
EXPAREL is available in 133 mg (10 mL) dose for $241.29 and 266 mg (20 mL) dose for $398.69. The 133 mg (10 mL) and 266 mg (20 mL) doses of EXPAREL are available in cartons of 4 and 10 vials. For more information please visit How to order EXPAREL.
Select Procedure Type
Information below helps review the value of EXPAREL in a multimodal pain management protocol that can lead to fewer opioids,* better pain control, and shorter LOS. These, in turn, can lead to fewer patient complications and reduced hospital costs per patient.
- Abdominal
- Spine
- Women's Health
- Orthopedic
Please select a procedure & study to see associated clinical and economic outcomes.
*The clinical benefit of the decrease in opioid consumption was not demonstrated in pivotal trials LOS, length of stay.
Laparoscopic Colorectal Surgery: Medical Center in Texas10
Study Methods
- 140 patients undergoing laparoscopic colorectal surgery: 70 received an ERP alone, and 70 received an ERP with EXPAREL
- Retrospective observational study
- All patients received the same ERP
Safety Outcomes
- 2.8% of patients in the ERP with EXPAREL group experienced a complication, compared with 7.8% of patients in the ERP-alone group
Clinical and Economic Outcomes
Patients who received ERP with EXPAREL to manage pain after surgery
Experienced significantly better pain control (P=0.001) in the PACU†- 1.92 vs 4.71
65% fewer opioids
consumed over 3 days*‡- Day 0: 1.16 vs 3.56 (P<0.001)
- Day 1: 1.31 vs 2.86 (P=0.031)
- Day 2: 1.28 vs 4.91 (P=0.02)
- Day 3: 0.86 vs 2.06 (P<0.001)
Had 1 day shorter LOS- 2.96 days vs 3.93 days (P=0.003)
Incurred $746 lower overall costs to the hospital§- $11,555.66 vs $12,302.08 (P=0.72)
ERP alone (n=70)
- Multimodal perioperative protocol with as-needed postsurgical opioids for analgesia
ERP with EXPAREL (n=70)
- Multimodal perioperative protocol with as-needed postsurgical opioids for analgesia
- Local wound infiltration with EXPAREL at the laparoscopic port site at the end of the procedure
- 20 mL vial of EXPAREL expanded with 20 mL of normal saline and 20 mL of 0.25% regular bupivacaine to a total volume of 60 mL
*The clinical benefit of the decrease in opioid consumption was not demonstrated in pivotal trials
†Pain was measured using a visual analog scale (0 to 10)
‡Opioid utilization was measured using the World Health Organization’s defined daily dose (DDD), converting each opioid used into the respective DDD (intravenous fentanyl [1 DDD = 100 mcg], intravenous dilaudid [1 DDD = 2 mg], oral dilaudid [1 DDD = 4 mg], oral oxycodone [1 DDD = 20 mg], and hydrocodone [1 DDD = 10 mg])
§Costs were defined as the actual per-patient total costs for the entire inpatient episode
ERP, enhanced recovery protocol; PACU, post-anesthesia care unit; LOS, length of stay.
Laparoscopic Colorectal Surgery: Medical Center in Texas10
Study Methods
- 140 patients undergoing laparoscopic colorectal surgery: 70 received an ERP alone, and 70 received an ERP with EXPAREL
- Retrospective observational study
- All patients received the same ERP
Safety Outcomes
- 2.8% of patients in the ERP with EXPAREL group experienced a complication, compared with 7.8% of patients in the ERP-alone group
Clinical and Economic Outcomes
Patients who received ERP with EXPAREL to manage pain after surgery
- Experienced significantly better pain control (P=0.001) in the PACU†
- 1.92 vs 4.71
- 1.92 vs 4.71
- 65% fewer opioids consumed over 3 days*‡
- Day 0: 1.16 vs 3.56 (P<0.001)
- Day 1: 1.31 vs 2.86 (P=0.031)
- Day 2: 1.28 vs 4.91 (P=0.02)
- Day 3: 0.86 vs 2.06 (P<0.001)
- Had 1 day shorter LOS
- 2.96 days vs 3.93 days (P=0.003)
- 2.96 days vs 3.93 days (P=0.003)
- Incurred $746 lower overall costs to the hospital§
- $11,555.66 vs $12,302.08 (P=0.72)
ERP alone (n=70)
- Multimodal perioperative protocol with as-needed postsurgical opioids for analgesia
ERP with EXPAREL (n=70)
- Multimodal perioperative protocol with as-needed postsurgical opioids for analgesia
- Local wound infiltration with EXPAREL at the laparoscopic port site at the end of the procedure
- 20 mL vial of EXPAREL expanded with 20 mL of normal saline and 20 mL of 0.25% regular bupivacaine to a total volume of 60 mL
*The clinical benefit of the decrease in opioid consumption was not demonstrated in pivotal trials
†Pain was measured using a visual analog scale (0 to 10)
‡Opioid utilization was measured using the World Health Organization’s defined daily dose (DDD), converting each opioid used into the respective DDD (intravenous fentanyl [1 DDD = 100 mcg], intravenous dilaudid [1 DDD = 2 mg], oral dilaudid [1 DDD = 4 mg], oral oxycodone [1 DDD = 20 mg], and hydrocodone [1 DDD = 10 mg])
§Costs were defined as the actual per-patient total costs for the entire inpatient episode
ERP, enhanced recovery protocol; PACU, post-anesthesia care unit; LOS, length of stay.
Minimally Invasive Surgery - Transforaminal Lumbar Interbody Fusion: Medical Center in Florida11
Study Methods
- 38 adult patients treated with enhanced recovery protocol after MIS TLIF were analyzed retrospectively and compared with 15 adult patients who underwent MIS TLIF before the implementation of ERP (N=53)
- All patients underwent standard MIS TLIF, but the control group did not receive all ERP components, including EXPAREL
Safety Outcomes
- The overall rate of complications was lower in the ERP group (12% versus 21%)†
Clinical and Economic Outcomes
Patients who received ERP with EXPAREL to manage pain after surgery had
2.7 days shorter length of stay- 1.2 vs 3.9 days (P=0.009)
$3,444 reduction in total cost for acute-care hospitalization‡- $19,212 vs $22,656 (P<0.001)
100% rate of discharge home- 100% vs 86%
Standard MIS TLIF (n=15)
- Standard surgical protocol utilizing 3 out of 6 ERP components
- Expandable cage
- Bone morphogenetic protein
- Small-caliber percutaneous screws
- General anesthesia
ERP with EXPAREL (n=38)
- ERP surgical protocol with all 6 components
- Local infiltration into the surgical site with EXPAREL expanded with saline and bupivacaine hydrochloride
- Anesthesia without intubation
- Working channel endoscope
- Expandable cage
- Bone morphogenetic protein
- Small-caliber percutaneous screws
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†The statistical significance of decreased complications was not evaluated
‡Areas of greatest savings included a reduction in intensive care unit costs, shorter overall LOS, and decreased costs from a reduced operating room duration
MIS, minimally invasive surgery; TLIF, transforaminal lumbar interbody fusion; ERP, enhanced recovery protocol; LOS, length of stay.
Minimally Invasive Surgery - Transforaminal Lumbar Interbody Fusion: Medical Center in Florida11
Study Methods
- 38 adult patients treated with enhanced recovery protocol after MIS TLIF were analyzed retrospectively and compared with 15 adult patients who underwent MIS TLIF before the implementation of ERP (N=53)
- All patients underwent standard MIS TLIF, but the control group did not receive all ERP components, including EXPAREL
Safety Outcomes
- The overall rate of complications was lower in the ERP group (12% versus 21%)†
Clinical and Economic Outcomes
Patients who received ERP with EXPAREL to manage pain after surgery had
- 2.7 days shorter length of stay
- 1.2 vs 3.9 days (P=0.009)
- 1.2 vs 3.9 days (P=0.009)
- $3,444 reduction in total cost for acute-care hospitalization‡
- $19,212 vs $22,656 (P<0.001)
- $19,212 vs $22,656 (P<0.001)
- 100% rate of discharge home
- 100% vs 86%
Standard MIS TLIF (n=15)
- Standard surgical protocol utilizing 3 out of 6 ERP components
- Expandable cage
- Bone morphogenetic protein
- Small-caliber percutaneous screws
- General anesthesia
ERP with EXPAREL (n=38)
- ERP surgical protocol with all 6 components
- Local infiltration into the surgical site with EXPAREL expanded with saline and bupivacaine hydrochloride
- Anesthesia without intubation
- Working channel endoscope
- Expandable cage
- Bone morphogenetic protein
- Small-caliber percutaneous screws
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†The statistical significance of decreased complications was not evaluated
‡Areas of greatest savings included a reduction in intensive care unit costs, shorter overall LOS, and decreased costs from a reduced operating room duration
MIS, minimally invasive surgery; TLIF, transforaminal lumbar interbody fusion; ERP, enhanced recovery protocol; LOS, length of stay.
Unilateral, Single-level Transforaminal lumbar Interbody Fusion: Medical Center in Massachusetts12
Study Methods
- 37 adult patients undergoing unilateral, single-level TLIF with EXPAREL compared with a historic control for the same procedure (N=74)
- Retrospective, observational study matched 1:1 to controls
- Surgical and treatment protocol was the same for both groups. In the EXPAREL group, EXPAREL was infiltrated at the conclusion of surgery in addition to the standard, nonliposomal local anesthetic received by the control group
- Cost was analyzed from the hospital perspective and savings per procedure were determined by the mean total costs for patients in both groups
- Means and standard deviations were analyzed for all presurgical and postsurgical outcomes
Safety Outcomes
- The overall rate of complications was identical in both groups (8.1%)
- No adverse events were attributed to the use of EXPAREL
Clinical and Economic Outcomes
Patients who received ERP with EXPAREL to manage pain after surgery had
Significantly better pain control reported in the first 24 hours†- 0 to 12 hours: 15.0 vs 45.6 (P=0.003)
- 12 to 24 hours: 37.6 vs 48.4 (P=0.05)
34% fewer opioids used at 12 to 24 hours*‡- 12 to 24 hours: 16.0 vs 24.1 (P=0.04)
1.2 days shorter LOS- 3.1 vs 4.3 days (P<0.001)
$590 lower mean total per-patient cost- $14,816 vs $15,406
ERP alone (n=37)
- Standard postsurgical treatment protocol
- Acetaminophen
- Oral and intravenous narcotics
- Oxycodone or hydromorphone
- Muscle relaxants
- Cyclobenzaprine, diazepam, or tizanidine
- Received an intraoperative injection of lidocaine or bupivacaine hydrochloride
ERP with EXPAREL (n=37)
- Identical ERP as in ERP-alone group
- Local infiltration into the surgical site with EXPAREL expanded with saline and bupivacaine hydrochloride
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Pain was self-reported by patients using the visual analog scale. Scores recorded over the first 3 days were divided into 12-hour intervals and used to calculate the area under the curve
‡Opioid consumption was measured using intravenous morphine milligram equivalent
TLIF, transforaminal lumbar interbody fusion; ERP, enhanced recovery protocol; LOS, length of stay.
Unilateral, Single-level Transforaminal lumbar Interbody Fusion: Medical Center in Massachusetts12
Study Methods
- 37 adult patients undergoing unilateral, single-level TLIF with EXPAREL compared with a historic control for the same procedure (N=74)
- Retrospective, observational study matched 1:1 to controls
- Surgical and treatment protocol was the same for both groups. In the EXPAREL group, EXPAREL was infiltrated at the conclusion of surgery in addition to the standard, nonliposomal local anesthetic received by the control group
- Cost was analyzed from the hospital perspective and savings per procedure were determined by the mean total costs for patients in both groups
- Means and standard deviations were analyzed for all presurgical and postsurgical outcomes
Safety Outcomes
- The overall rate of complications was identical in both groups (8.1%)
- No adverse events were attributed to the use of EXPAREL
Clinical and Economic Outcomes
Patients who received ERP with EXPAREL to manage pain after surgery had
- Significantly better pain control reported in the first 24 hours†
- 0 to 12 hours: 15.0 vs 45.6 (P=0.003)
- 12 to 24 hours: 37.6 vs 48.4 (P=0.05)
- 34% fewer opioids used at 12 to 24 hours*‡
- 12 to 24 hours: 16.0 vs 24.1 (P=0.04)
- 1.2 days shorter LOS
- 3.1 vs 4.3 days (P<0.001)
- $590 lower mean total per-patient cost
- $14,816 vs $15,406
ERP alone (n=37)
- Standard postsurgical treatment protocol
- Acetaminophen
- Oral and intravenous narcotics
- Oxycodone or hydromorphone
- Muscle relaxants
- Cyclobenzaprine, diazepam, or tizanidine
- Received an intraoperative injection of lidocaine or bupivacaine hydrochloride
ERP with EXPAREL (n=37)
- Identical ERP as in ERP-alone group
- Local infiltration into the surgical site with EXPAREL expanded with saline and bupivacaine hydrochloride
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Pain was self-reported by patients using the visual analog scale. Scores recorded over the first 3 days were divided into 12-hour intervals and used to calculate the area under the curve
‡Opioid consumption was measured using intravenous morphine milligram equivalent
TLIF, transforaminal lumbar interbody fusion; ERP, enhanced recovery protocol; LOS, length of stay.
Implant-Based Breast Reconstruction: Medical Center in California13
Study Methods
- 12 adult patients undergoing mastectomy with EXPAREL compared with 12 adult patients undergoing mastectomy with bupivacaine
- Prospective, randomized, single-blind trial
- Basic statistical analyses were performed and included pain scores, opioid consumption, benzodiazepine consumption, antiemetic consumption, LOS, and hospital costs
Safety Outcomes
- No significant adverse events were noted in either group
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
47% lower opioid consumption during hospital stay*†- 0.76 vs 1.43 MED/hour
- 22.6 vs 66.8 for entire LOS duration‡
16.9 hours
shorter LOS- 29.8 vs 46.7 hours
$7804 lower
hospital charges- $10,828 vs $18,632
Breast reconstruction with EXPAREL (n=12)
- Intrasurgical injection of 1.3% EXPAREL, with 10 mL (133 mg) delivered to perform a field block of each breast pocket
- Infiltration sites included the pectoralis major muscle, along the ipsilateral parasternal line, along a line 1 cm posterior and parallel to the anterior axillary line, extending under the pectoralis major muscle in the axilla, the base of the mastectomy flaps, and any locations where deep sutures were placed to anchor acellular dermal matrices along the chest wall and pectoralis major muscle
- Standard postoperative drug regimen for pain (hydrocodone/acetaminophen and/or hydromorphone), muscle spasms (diazepam), and nausea and vomiting (ondansetron)
- Included 3 unilateral and 9 bilateral procedures
Breast reduction with bupivacaine (n=12)
- Intrasurgical injection of 0.25% bupivacaine and epinephrine (1:200,000), with 20 mL (50 mg) delivered to perform a field block of each breast pocket§
- Infiltration sites included the pectoralis major muscle, along the ipsilateral parasternal line, along a line 1 cm posterior and parallel to the anterior axillary line, extending under the pectoralis major muscle in the axilla, the base of the mastectomy flaps, and any locations where deep sutures were placed to anchor acellular dermal matrices along the chest wall and pectoralis major muscle
- Standard postoperative drug regimen for pain (hydrocodone/acetaminophen and/or hydromorphone), muscle spasms (diazepam), and nausea and vomiting (ondansetron)
- Included 2 unilateral and 10 bilateral procedures
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Opioid consumption was noted and converted to MED per hour of hospital stay
‡Projected value calculated using study data for each respective cohort. The EXPAREL figure is based on 0.76 MED/hour and a 29.8-hour LOS. The bupivacaine figure is based on 1.43 MED/hour and a 46.7-hour LOS
§The use of EXPAREL in combination with epinephrine is not part of the approved label
LOS, length of stay; MED, morphine equivalent dosing.
Implant-Based Breast Reconstruction: Medical Center in California13
Study Methods
- 12 adult patients undergoing mastectomy with EXPAREL compared with 12 adult patients undergoing mastectomy with bupivacaine
- Prospective, randomized, single-blind trial
- Basic statistical analyses were performed and included pain scores, opioid consumption, benzodiazepine consumption, antiemetic consumption, LOS, and hospital costs
Safety Outcomes
- No significant adverse events were noted in either group
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- 47% lower opioid consumption during hospital stay*†
- 0.76 vs 1.43 MED/hour
- 22.6 vs 66.8 for entire LOS duration‡
- 16.9 hours shorter LOS
- 29.8 vs 46.7 hours
- $7804 lower hospital charges
- $10,828 vs $18,632
Breast reconstruction with EXPAREL (n=12)
- Intrasurgical injection of 1.3% EXPAREL, with 10 mL (133 mg) delivered to perform a field block of each breast pocket
- Infiltration sites included the pectoralis major muscle, along the ipsilateral parasternal line, along a line 1 cm posterior and parallel to the anterior axillary line, extending under the pectoralis major muscle in the axilla, the base of the mastectomy flaps, and any locations where deep sutures were placed to anchor acellular dermal matrices along the chest wall and pectoralis major muscle
- Standard postoperative drug regimen for pain (hydrocodone/acetaminophen and/or hydromorphone), muscle spasms (diazepam), and nausea and vomiting (ondansetron)
- Included 3 unilateral and 9 bilateral procedures
Breast reduction with bupivacaine (n=12)
- Intrasurgical injection of 0.25% bupivacaine and epinephrine (1:200,000), with 20 mL (50 mg) delivered to perform a field block of each breast pocket§
- Infiltration sites included the pectoralis major muscle, along the ipsilateral parasternal line, along a line 1 cm posterior and parallel to the anterior axillary line, extending under the pectoralis major muscle in the axilla, the base of the mastectomy flaps, and any locations where deep sutures were placed to anchor acellular dermal matrices along the chest wall and pectoralis major muscle
- Standard postoperative drug regimen for pain (hydrocodone/acetaminophen and/or hydromorphone), muscle spasms (diazepam), and nausea and vomiting (ondansetron)
- Included 2 unilateral and 10 bilateral procedures
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Opioid consumption was noted and converted to MED per hour of hospital stay
‡Projected value calculated using study data for each respective cohort. The EXPAREL figure is based on 0.76 MED/hour and a 29.8-hour LOS. The bupivacaine figure is based on 1.43 MED/hour and a 46.7-hour LOS
§The use of EXPAREL in combination with epinephrine is not part of the approved label
LOS, length of stay; MED, morphine equivalent dosing.
Implant-Based Breast Reconstruction: Medical Center in Illinois14
Study Methods
- Adult patients (N=90) undergoing mastectomy and immediate implant-based breast reconstruction with or without lymph node dissection. All patients had the same postsurgical pain control regimens with hydromorphone hydrochloride PCA or morphine PCA, were transitioned to oral narcotics on the first postsurgical day, and received the same postsurgical orders, including as-needed antinausea medications, pruritus medications, and scheduled cyclobenzaprine. Patients were divided into 3 groups based on analgesia:
- Patients who received EXPAREL
- Patients who received NDB in a pain pump
- Patients in the control group who received IV PCA or oral narcotics
- Retrospective chart review
- Multiple linear regression analyses were performed to assess how identified factors impacted LOS
Safety Outcomes
- No complications were noted in the EXPAREL group
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Significantly better pain control (P<0.01) 4, 8, 12, 16, and 24 hours postsurgery†- Significantly lower pain versus
NDB and PCA
67% patients discharged home after 1 day- EXPAREL group: 20 of 30 (67%)
- NDB group: 13 of 30 (43%)
- Control group: 9 of 30 (30%)
Breast reconstruction with EXPAREL (n=30)
- 20 mL of EXPAREL were infiltrated in unilateral breast reconstruction
- 20 mL of EXPAREL were expanded with 10 mL of saline in bilateral breast reconstruction, with 15 mL total infiltrated into each breast
- Included 6 unilateral and 24 bilateral procedures
- Patients who received implantation of an ADM had an additional 3 mL of EXPAREL infiltrated around the suture sites. All patients in this group received an ADM
Breast reconstruction with NDB pump (n=30)
- Pain pump placed in subpectoral plane underneath implant in a pocket separate from the drain
- Included 14 unilateral and 16 bilateral procedures
Breast reconstruction with PCA/oral narcotics control group (n=30)
- No regional anesthesia or intraoperative lidocaine or bupivacaine
- IV PCA or oral narcotics
- Included 14 unilateral and 16 bilateral procedures
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†All pain was measured with the visual analog scale
ADM, acellular dermal matrix; IV, intravenous; NDB, non-depot bupivacaine; PCA, patient-controlled analgesia; LOS, length of stay.
Implant-Based Breast Reconstruction: Medical Center in Illinois14
Study Methods
- Adult patients (N=90) undergoing mastectomy and immediate implant-based breast reconstruction with or without lymph node dissection. All patients had the same postsurgical pain control regimens with hydromorphone hydrochloride PCA or morphine PCA, were transitioned to oral narcotics on the first postsurgical day, and received the same postsurgical orders, including as-needed antinausea medications, pruritus medications, and scheduled cyclobenzaprine. Patients were divided into 3 groups based on analgesia:
- Patients who received EXPAREL
- Patients who received NDB in a pain pump
- Patients in the control group who received IV PCA or oral narcotics
- Retrospective chart review
- Multiple linear regression analyses were performed to assess how identified factors impacted LOS
Safety Outcomes
- No complications were noted in the EXPAREL group
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- Significantly better pain control (P<0.01) 4, 8, 12, 16, and 24 hours postsurgery†
- Significantly lower pain versus NDB and PCA
- 67% patients discharged home after 1 day
- EXPAREL group: 20 of 30 (67%)
- NDB group: 13 of 30 (43%)
- Control group: 9 of 30 (30%)
Breast reconstruction with EXPAREL (n=30)
- 20 mL of EXPAREL were infiltrated in unilateral breast reconstruction
- 20 mL of EXPAREL were expanded with 10 mL of saline in bilateral breast reconstruction, with 15 mL total infiltrated into each breast
- Included 6 unilateral and 24 bilateral procedures
- Patients who received implantation of an ADM had an additional 3 mL of EXPAREL infiltrated around the suture sites. All patients in this group received an ADM
Breast reconstruction with NDB pump (n=30)
- Pain pump placed in subpectoral plane underneath implant in a pocket separate from the drain
- Included 14 unilateral and 16 bilateral procedures
Breast reconstruction with PCA/oral narcotics control group (n=30)
- No regional anesthesia or intraoperative lidocaine or bupivacaine
- IV PCA or oral narcotics
- Included 14 unilateral and 16 bilateral procedures
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†All pain was measured with the visual analog scale
ADM, acellular dermal matrix; IV, intravenous; NDB, non-depot bupivacaine; PCA, patient-controlled analgesia; LOS, length of stay.
Abdominally Based Microsurgical Breast Reconstruction: Medical Center in New York15
Study Methods
- 128 adult patients undergoing breast reconstruction using abdominally based free flaps with or without a non-narcotic protocol using intraoperative TAP blockade. Patients were divided into a control group, a TAP catheter group, and a TAP EXPAREL group
- Retrospective observational study
- Primary and secondary outcomes were assessed for associations and adjusted for confounding variables
Safety Outcomes
- The overall complication rate was 8.7%, with no significant differences between the groups
- The TAP catheter group noted higher rates of transfusions (P=0.0084)
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Fewer total opioids used after surgery vs catheter and control groups (mg)*†- Day 0–1: 1.88 vs 7.25 (P=0.0081) vs 52.86 (P<0.0001)
- Day 2: 2.12 vs 5.17 (P=0.0270) vs 29.9 (P=0.0009)
0.9 to 1.4 days shorter LOS- EXPAREL group: 2.65 days
- TAP catheter group: 3.52 days
- Control group: 4.05 days
Breast reconstruction with TAP EXPAREL (n=40)
- 15 mg of IV ketorolac and 1000 mg of IV acetaminophen at the end of surgery and then every 6 hours postsurgery
- After tolerance of an oral diet, patients switched to an oral regimen of 10 mg of ketorolac and 650 mg of acetaminophen, with oral opioids as needed for breakthrough pain
- A mixture of 20 mL of 1.3% EXPAREL, 30 mL of standard bupivacaine, and 80 mL of normal saline infiltrated at 30 mL into each side
- After tolerance of an oral diet, patients switched to an oral regimen of 10 mg of ketorolac and 650 mg of acetaminophen, with oral opioids as needed for breakthrough pain
Breast reconstruction with TAP catheter (n=48)
- 15 mg of IV ketorolac and 1000 mg of IV acetaminophen at the end of surgery and then every 6 hours postsurgery
- After tolerance of an oral diet, patients switched to an oral regimen of 10 mg of ketorolac and 650 mg of acetaminophen, with oral opioids as needed for breakthrough pain
- 30 mL of 0.25% bupivacaine injected bilaterally, followed by transcutaneous passing of bilateral epidural catheters into the plane and connected to a 400-mL capacity fixed-rate pump filled with 0.25% bupivacaine delivered through each catheter at 2 mL per hour
Breast reconstruction with narcotic-based analgesia control group (n=40)
- Standard narcotic-based analgesia regimen without locoregional anesthesia
- IV PCA opioid pump with additional nurse-administered opioids for breakthrough pain, followed by transition to an as-needed oral opioid
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Opioid consumption was measured using IV morphine equivalent (mg)
TAP, transversus abdominis plane.
Abdominally Based Microsurgical Breast Reconstruction: Medical Center in New York15
Study Methods
- 128 adult patients undergoing breast reconstruction using abdominally based free flaps with or without a non-narcotic protocol using intraoperative TAP blockade. Patients were divided into a control group, a TAP catheter group, and a TAP EXPAREL group
- Retrospective observational study
- Primary and secondary outcomes were assessed for associations and adjusted for confounding variables
Safety Outcomes
- The overall complication rate was 8.7%, with no significant differences between the groups
- The TAP catheter group noted higher rates of transfusions (P=0.0084)
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- Fewer total opioids used after surgery vs catheter and control groups (mg)*†
- Day 0–1: 1.88 vs 7.25 (P=0.0081) vs 52.86 (P<0.0001)
- Day 2: 2.12 vs 5.17 (P=0.0270) vs 29.9 (P=0.0009)
- 0.9 to 1.4 days shorter LOS
- EXPAREL group: 2.65 days
- TAP catheter group: 3.52 days
- Control group: 4.05 days
Breast reconstruction with TAP EXPAREL (n=40)
- 15 mg of IV ketorolac and 1000 mg of IV acetaminophen at the end of surgery and then every 6 hours postsurgery
- After tolerance of an oral diet, patients switched to an oral regimen of 10 mg of ketorolac and 650 mg of acetaminophen, with oral opioids as needed for breakthrough pain
- A mixture of 20 mL of 1.3% EXPAREL, 30 mL of standard bupivacaine, and 80 mL of normal saline infiltrated at 30 mL into each side
- After tolerance of an oral diet, patients switched to an oral regimen of 10 mg of ketorolac and 650 mg of acetaminophen, with oral opioids as needed for breakthrough pain
Breast reconstruction with TAP catheter (n=48)
- 15 mg of IV ketorolac and 1000 mg of IV acetaminophen at the end of surgery and then every 6 hours postsurgery
- After tolerance of an oral diet, patients switched to an oral regimen of 10 mg of ketorolac and 650 mg of acetaminophen, with oral opioids as needed for breakthrough pain
- 30 mL of 0.25% bupivacaine injected bilaterally, followed by transcutaneous passing of bilateral epidural catheters into the plane and connected to a 400-mL capacity fixed-rate pump filled with 0.25% bupivacaine delivered through each catheter at 2 mL per hour
Breast reconstruction with narcotic-based analgesia control group (n=40)
- Standard narcotic-based analgesia regimen without locoregional anesthesia
- IV PCA opioid pump with additional nurse-administered opioids for breakthrough pain, followed by transition to an as-needed oral opioid
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Opioid consumption was measured using IV morphine equivalent (mg)
TAP, transversus abdominis plane.
Microvascular Breast Reconstruction: Medical Center in Minnesota16
Study Methods
- 49 adult patients undergoing microvascular breast reconstruction with EXPAREL as part of an ERAS protocol compared with 51 adult patients undergoing microvascular breast reconstruction with TRAS before development of the ERAS protocol
- Retrospective cohort study
- Characteristics were compared between the 2 groups, and a multivariable regression analysis was used on continuous outcome variables to account for baseline differences between the 2 groups
Safety Outcomes
- No significant differences between the 2 groups in relation to 30-day complications
- The ERAS group experienced an increased incidence of native breast skin flap cellulitis compared with the group without ERAS (20% vs 6%, respectively; P=0.03)
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Significantly better pain control (P=0.02) 24 hours postsurgery†- 24 hours: 3.3 vs 4.1 (P=0.02)
71% fewer total opioids used postsurgery (mg)*‡- Total: 167.3 vs 574.3 (P<0.001)
- Day 1: 67.3 vs 260.9 (P<0.001)
- Day 2: 53.5 vs 192.2 (P<0.001)
- Day 3: 39.0 vs 113.1 (P<0.001)
1.6 days shorter
LOS postsurgery- Total: 3.9 vs 5.5 days (P<0.001)
Microvascular reconstruction with EXPAREL as part of ERAS (n=49)
- All procedures included use of EXPAREL expanded with saline and infiltrated as a subfascial TAP block into the rectus sheath(s) and into subcutaneous tissues at the lower abdominal incision
- Local anesthesia or pain pump catheters were not used
- Included 9 unilateral and 40 bilateral procedures
Microvascular reconstruction with TRAS (n=51)
- 5 procedures included use of EXPAREL prior to standardization of EXPAREL use as part of all ERAS procedures
- EXPAREL was expanded with saline and infiltrated as a subfascial TAP block into the rectus sheath(s) and into subcutaneous tissues at the lower abdominal incision
- Included use of local anesthesia and pain pump catheters
- Included 10 unilateral and 41 bilateral procedures
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†All pain was measured using the visual analog scale
‡Parenteral and oral opioid intake was converted into oral morphine equivalents (mg) using standardized calculations
ERAS, enhanced recovery after surgery; TRAS, traditional recovery after surgery; LOS, length of stay.
Microvascular Breast Reconstruction: Medical Center in Minnesota16
Study Methods
- 49 adult patients undergoing microvascular breast reconstruction with EXPAREL as part of an ERAS protocol compared with 51 adult patients undergoing microvascular breast reconstruction with TRAS before development of the ERAS protocol
- Retrospective cohort study
- Characteristics were compared between the 2 groups, and a multivariable regression analysis was used on continuous outcome variables to account for baseline differences between the 2 groups
Safety Outcomes
- No significant differences between the 2 groups in relation to 30-day complications
- The ERAS group experienced an increased incidence of native breast skin flap cellulitis compared with the group without ERAS (20% vs 6%, respectively; P=0.03)
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- Significantly better pain control (P=0.02) 24 hours postsurgery†
- 24 hours: 3.3 vs 4.1 (P=0.02)
- 71% fewer total opioids used postsurgery (mg)*‡
- Total: 167.3 vs 574.3 (P<0.001)
- Day 1: 67.3 vs 260.9 (P<0.001)
- Day 2: 53.5 vs 192.2 (P<0.001)
- Day 3: 39.0 vs 113.1 (P<0.001)
- 1.6 days shorter LOS postsurgery
- Total: 3.9 vs 5.5 days (P<0.001)
Microvascular reconstruction with EXPAREL as part of ERAS (n=49)
- All procedures included use of EXPAREL expanded with saline and infiltrated as a subfascial TAP block into the rectus sheath(s) and into subcutaneous tissues at the lower abdominal incision
- Local anesthesia or pain pump catheters were not used
- Included 9 unilateral and 40 bilateral procedures
Microvascular reconstruction with TRAS (n=51)
- 5 procedures included use of EXPAREL prior to standardization of EXPAREL use as part of all ERAS procedures
- EXPAREL was expanded with saline and infiltrated as a subfascial TAP block into the rectus sheath(s) and into subcutaneous tissues at the lower abdominal incision
- Included use of local anesthesia and pain pump catheters
- Included 10 unilateral and 41 bilateral procedures
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†All pain was measured using the visual analog scale
‡Parenteral and oral opioid intake was converted into oral morphine equivalents (mg) using standardized calculations
ERAS, enhanced recovery after surgery; TRAS, traditional recovery after surgery; LOS, length of stay.
Gynecologic Oncology Robotic-Assisted Hysterectomy: Medical Center in Minnesota17
Study Methods
- 60 adult patients undergoing robotic-assisted hysterectomy: 30 received a transversus abdominis plane block with EXPAREL, and 30 did not receive a TAP block
- Retrospective observational study
- All patients received intraoperative and postsurgical opioids
Safety Outcomes
- 3.3% of patients in the TAP block EXPAREL group had a postsurgical complication, compared with 20% in the group of patients who did not receive a TAP block
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Significantly less pain (P=0.05) over first 24 hours after infiltration†- 5 vs 7 on 11-point scale†
16.2 hours
shorter LOS- 11.5 vs 27.7 hours (P>0.0001)
63% fewer occurrences
of nausea or vomiting- 20% vs 53.3% (P=0.02)
Hysterectomy without TAP block (n=30)
- Intraoperative and postsurgical opioid-based analgesia regimen
Hysterectomy with TAP block and EXPAREL (n=30)
- Intraoperative and postsurgical opioid-based analgesia regimen
- A subcostal TAP block was performed under ultrasound guidance with a 22-gauge 30º beveled needle. After the needle pierced the transversus abdominis fascia, three 10-mL syringes of local anesthetic were injected. The first syringe contained 10 mL of 0.25% bupivacaine with epinephrine (1:200,000), and the other 2 syringes each contained 5 mL of EXPAREL and 5 mL of 0.9% preservative-free normal saline‡
- This process was repeated on the contralateral side
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Difference in pain scores remained statistically significant after adjustments for potential confounders (P=0.004)
‡The use of EXPAREL in combination with epinephrine is not part of the approved label
TAP, transversus abdominis plane; LOS, length of stay.
Gynecologic Oncology Robotic-Assisted Hysterectomy: Medical Center in Minnesota17
Study Methods
- 60 adult patients undergoing robotic-assisted hysterectomy: 30 received a transversus abdominis plane block with EXPAREL, and 30 did not receive a TAP block
- Retrospective observational study
- All patients received intraoperative and postsurgical opioids
Safety Outcomes
- 3.3% of patients in the TAP block EXPAREL group had a postsurgical complication, compared with 20% in the group of patients who did not receive a TAP block
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- Significantly less pain (P=0.05) over first 24 hours after infiltration†
- 5 vs 7 on 11-point scale†
- 16.2 hours shorter LOS
- 11.5 vs 27.7 hours (P>0.0001)
- 63% fewer occurrences of nausea or vomiting
- 20% vs 53.3% (P=0.02)
Hysterectomy without TAP block (n=30)
- Intraoperative and postsurgical opioid-based analgesia regimen
Hysterectomy with TAP block and EXPAREL (n=30)
- Intraoperative and postsurgical opioid-based analgesia regimen
- A subcostal TAP block was performed under ultrasound guidance with a 22-gauge 30º beveled needle. After the needle pierced the transversus abdominis fascia, three 10-mL syringes of local anesthetic were injected. The first syringe contained 10 mL of 0.25% bupivacaine with epinephrine (1:200,000), and the other 2 syringes each contained 5 mL of EXPAREL and 5 mL of 0.9% preservative-free normal saline‡
- This process was repeated on the contralateral side
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Difference in pain scores remained statistically significant after adjustments for potential confounders (P=0.004)
‡The use of EXPAREL in combination with epinephrine is not part of the approved label
TAP, transversus abdominis plane; LOS, length of stay.
Cesarean Section: Medical Center in Texas18
Study Methods
- Adult patients (N=201) who underwent elective, unscheduled waiting list, or emergency cesarean delivery with an EXPAREL TAP block (n=101) compared with patients who did not receive an EXPAREL TAP block (n=100)
- Retrospective chart review
Safety Outcomes
- Patients treated with EXPAREL reported fewer adverse events, such as nausea, vomiting, or pruritus (34% vs 50%; P=0.026)
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Significantly better pain control (P<0.001)- 132.8 vs 246.3 (P<0.001) of total AUC of NRS pain scores from 0 to 3 days
47% reduction in postsurgical opioid consumption through 3 days*- Total postsurgical opioid consumption (MED), mg: 41.9 vs 79.6 (P<0.001)
1 Day shorter LOS- 26% reduction in LOS (2.9 days vs
3.9 days; P<0.001)
- 19% reduction in time to discharge readiness (2.9 days vs 3.6 days; P=0.006)
15% reduction in PACU discharge readiness time (25 minutes)- 138 minutes vs 163 minutes (P=0.028)
39% reduction in time to ambulation- 18.7 hours vs 30.7 hours; P<0.001
Multimodal protocol (n=100)
- Spinal-epidural anesthesia with intrathecal morphine and supplemental IV analgesia
- Supplemental analgesia was based on patient reported pain scores†
- NRS 1 to 5: 3 doses of IV acetaminophen 10 mg/mL (15 mg/kg if body weight <50 kg) every 6 hours alternating with 3 doses of IV ketorolac 30 mg every 6 hours for 24 hours
- NRS 6 to 10: IV nalbuphine 2 mg every 2 hours as needed for breakthrough pain for 24 hours
Multimodal protocol with EXPAREL TAP block (n=101)
- Ultrasound-guided TAP block with EXPAREL 266 mg/20 mL admixed with 30 mL of bupivacaine HCl 0.25% and 30 mL of normal saline, equaling 40 mL injected on each side (total volume: 80 mL)
- Spinal-epidural anesthesia with intrathecal morphine and supplemental IV analgesia
- Supplemental analgesia was based on patient reported pain scores†
- NRS 1 to 5: 3 doses of IV acetaminophen 10 mg/mL (15 mg/kg if body weight <50 kg) every 6 hours alternating with 3 doses of IV ketorolac 30 mg every 6 hours for 24 hours
- NRS 6 to 10: IV nalbuphine 2 mg every 2 hours as needed for breakthrough pain for 24 hours
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†The NRS scale used ranged from 0, representing no pain, to 10, representing the worst possible pain
AUC, area under the curve; NRS, numerical rating scale; TAP, transversus abdominis plane; LOS, length of stay; MED, morphine equivalent doses; PACU, postanesthesia care unit.
Cesarean Section: Medical Center in Texas18
Study Methods
- Adult patients (N=201) who underwent elective, unscheduled waiting list, or emergency cesarean delivery with an EXPAREL TAP block (n=101) compared with patients who did not receive an EXPAREL TAP block (n=100)
- Retrospective chart review
Safety Outcomes
- Patients treated with EXPAREL reported fewer adverse events, such as nausea, vomiting, or pruritus (34% vs 50%; P=0.026)
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- Significantly better pain control (P<0.001)
- 132.8 vs 246.3 (P<0.001) of total AUC of NRS pain scores from 0 to 3 days
- 47% reduction in postsurgical opioid consumption through 3 days*
- Total postsurgical opioid consumption (MED), mg: 41.9 vs 79.6 (P<0.001)
- 1 Day shorter LOS
- 26% reduction in LOS (2.9 days vs 3.9 days; P<0.001)
- 19% reduction in time to discharge readiness (2.9 days vs 3.6 days; P=0.006)
- 15% reduction in PACU discharge readiness time (25 minutes)
- 138 minutes vs 163 minutes (P=0.028)
- 39% reduction in time to ambulation
- 18.7 hours vs 30.7 hours; P<0.001
Multimodal protocol (n=100)
- Spinal-epidural anesthesia with intrathecal morphine and supplemental IV analgesia
- Supplemental analgesia was based on patient reported pain scores†
- NRS 1 to 5: 3 doses of IV acetaminophen 10 mg/mL (15 mg/kg if body weight <50 kg) every 6 hours alternating with 3 doses of IV ketorolac 30 mg every 6 hours for 24 hours
- NRS 6 to 10: IV nalbuphine 2 mg every 2 hours as needed for breakthrough pain for 24 hours
Multimodal protocol with EXPAREL TAP block (n=101)
- Ultrasound-guided TAP block with EXPAREL 266 mg/20 mL admixed with 30 mL of bupivacaine HCl 0.25% and 30 mL of normal saline, equaling 40 mL injected on each side (total volume: 80 mL)
- Spinal-epidural anesthesia with intrathecal morphine and supplemental IV analgesia
- Supplemental analgesia was based on patient reported pain scores†
- NRS 1 to 5: 3 doses of IV acetaminophen 10 mg/mL (15 mg/kg if body weight <50 kg) every 6 hours alternating with 3 doses of IV ketorolac 30 mg every 6 hours for 24 hours
- NRS 6 to 10: IV nalbuphine 2 mg every 2 hours as needed for breakthrough pain for 24 hours
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†The NRS scale used ranged from 0, representing no pain, to 10, representing the worst possible pain
AUC, area under the curve; NRS, numerical rating scale; TAP, transversus abdominis plane; LOS, length of stay; MED, morphine equivalent doses; PACU, postanesthesia care unit.
Total Hip Arthroplasty: ASCs in Tennessee19
Study Methods
- 145 outpatient THAs in 125 patients performed with the use of EXPAREL by a single surgeon in 2 separate stand-alone ASCs
- Retrospective chart review
Safety Outcomes
- 1 recognized intraoperative fracture, which did not compromise same-day discharge
- 5 unanticipated complications (3.4%) in global period postsurgery
Clinical and Economic Outcomes
In patients who received EXPAREL to manage pain after surgery
Complication rates compared favorably with those reported after standard inpatient THA
99.3% of cases did not require a transfer to the hospital for transfusion- 0% of patients required other direct admissions to the hospital or ED
Average surgical time was 71 minutes and total LOS was 10.8 hours
98% of cases did not require surgical intervention within a 90-day period- Persistent drainage 6 weeks postsurgery that required debridement/irrigation with head/liner exchange
- Periprosthetic fracture from a same-level fall at home 7 days postsurgery that required revision surgery
- Outpatient superficial wound revision, 4 weeks postsurgery
THA (N=145)
- Preoperative regimen - Oral celecoxib 400 mg, gabapentin 300 mg, oxycodone 10 or 20 mg, and oral or intravenous acetaminophen 1000 mg
- Intraoperative regimen - 0.75% bupivacaine with 8.25% dextrose 10 to 15 mg spinal, EXPAREL 266 mg infiltrated into wound, and intravenous dexamethasone 4 to 8 mg
- Postsurgical regimen - Oral celecoxib 200 mg 4 times daily or meloxicam 7.5 mg 2 times daily, oral gabapentin 300 mg 2 times daily, oral tramadol 50 mg every 6 hours, oral acetaminophen 1000 mg every 8 hours, and oral oxycodone 5 to 10 mg every 4 to 6 hours as needed
- Spinal anesthesia was used in 132 procedures with bupivacaine (10.5-15 mg) and general endotracheal anesthesia was used in 13 patients due to previous spinal fusion, preexisting neuropathy, or intraoperative conversion secondary to unsuccessful spinal anesthesia
- Included 105 unilateral procedures and 20 bilateral procedures
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
ASC, ambulatory surgery center; ED, emergency department; LOS, length of stay; THA, total hip arthroplasty.
Total Hip Arthroplasty: ASCs in Tennessee19
Study Methods
- 145 outpatient THAs in 125 patients performed with the use of EXPAREL by a single surgeon in 2 separate stand-alone ASCs
- Retrospective chart review
Safety Outcomes
- 1 recognized intraoperative fracture, which did not compromise same-day discharge
- 5 unanticipated complications (3.4%) in global period postsurgery
Clinical and Economic Outcomes
In patients who received EXPAREL to manage pain after surgery
- Complication rates compared favorably with those reported after standard inpatient THA
- 99.3% of cases did not require a transfer to the hospital for transfusion
- 0% of patients required other direct admissions to the hospital or ED
- Average surgical time was 71 minutes and total LOS was 10.8 hours
- 98% of cases did not require surgical intervention within a 90-day period
- Persistent drainage 6 weeks postsurgery that required debridement/irrigation with head/liner exchange
- Periprosthetic fracture from a same-level fall at home 7 days postsurgery that required revision surgery
- Outpatient superficial wound revision, 4 weeks postsurgery
THA (N=145)
- Preoperative regimen - Oral celecoxib 400 mg, gabapentin 300 mg, oxycodone 10 or 20 mg, and oral or intravenous acetaminophen 1000 mg
- Intraoperative regimen - 0.75% bupivacaine with 8.25% dextrose 10 to 15 mg spinal, EXPAREL 266 mg infiltrated into wound, and intravenous dexamethasone 4 to 8 mg
- Postsurgical regimen - Oral celecoxib 200 mg 4 times daily or meloxicam 7.5 mg 2 times daily, oral gabapentin 300 mg 2 times daily, oral tramadol 50 mg every 6 hours, oral acetaminophen 1000 mg every 8 hours, and oral oxycodone 5 to 10 mg every 4 to 6 hours as needed
- Spinal anesthesia was used in 132 procedures with bupivacaine (10.5-15 mg) and general endotracheal anesthesia was used in 13 patients due to previous spinal fusion, preexisting neuropathy, or intraoperative conversion secondary to unsuccessful spinal anesthesia
- Included 105 unilateral procedures and 20 bilateral procedures
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
ASC, ambulatory surgery center; ED, emergency department; LOS, length of stay; THA, total hip arthroplasty.
Total Joint Arthroplasty Study20,21: Medicare and Commercial
Background
Two studies analyzed the impact that EXPAREL, as part of an ERAS pathway, had on same-day discharge. The Medicare-focused study analyzed the outcome and feasibility of same-day discharge using an ERAS protocol in the inpatient setting, while the commercial insurance-focused study analyzed outcomes in an ASC.
- Medicare: Orthopedic center in Oregon
- Commercial: ASC in Oregon
Study Methods
- Medicare and Commercial: Retrospective chart review
- Medicare: 601 unique patients who underwent primary TKA (n=337) or THA (n=308) with the use of EXPAREL
- Commercial: 220 unique patients who underwent primary TKA (n=113) or THA (n=138) with the use of EXPAREL in a freestanding ASC
Safety Outcomes
- Medicare: Within 30 days after surgery, 1.1% of patients experienced a severe AE and 0.5% of patients experienced a minor AE
- Commercial: Within 30 days after surgery, 6 patients experienced a severe AE and 1 patient experienced a minor AE
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Same-day discharge- Medicare: 84% of patients were discharged on the day of surgery
- Commercial: 100% of patients were discharged on the day of surgery
High pain management satisfaction- Medicare: 98.3% of patients were “very much” or a “good amount” satisfied with pain management
- Commercial: 99.3% of patients were “very much” or a “good amount” satisfied with pain management
Postsurgical opioid use- Medicare: 84.2% of patients did not require an opioid prescription beyond the initial 7-day prescription provided at discharge*
TJA: Medicare (N=601) and commercial (N=220)
- Individualized preoperative opioid analgesia protocol
- Non-opioid analgesia protocol consisting of acetaminophen, meloxicam, or celecoxib utilized 1 week before surgery and for 6 weeks after surgery
- Spinal anesthesia
- Periarticular infiltration with EXPAREL 266 mg, bupivacaine HCl, and adjuncts
- Restricted intravenous opioids during surgery
THA: Medicare (n=308) and commercial (n=138)
- Anterior lateral femoral cutaneous nerve field block with EXPAREL 266 mg and bupivacaine HCl
TKA: Medicare (n=337) and commercial (n=113)
- Adductor canal block with bupivacaine HCl
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials
AE, adverse event; ASC, ambulatory surgery center; ERAS, enhanced recovery after surgery; THA, total hip arthroplasty; TJA, total joint arthroplasty; TKA, total knee arthroplasty.
Total Joint Arthroplasty Study20,21: Medicare and Commercial
Background
Two studies analyzed the impact that EXPAREL, as part of an ERAS pathway, had on same-day discharge. The Medicare-focused study analyzed the outcome and feasibility of same-day discharge using an ERAS protocol in the inpatient setting, while the commercial insurance-focused study analyzed outcomes in an ASC.
- Medicare: Orthopedic center in Oregon
- Commercial: ASC in Oregon
Study Methods
- Medicare and Commercial: Retrospective chart review
- Medicare: 601 unique patients who underwent primary TKA (n=337) or THA (n=308) with the use of EXPAREL
- Commercial: 220 unique patients who underwent primary TKA (n=113) or THA (n=138) with the use of EXPAREL in a freestanding ASC
Safety Outcomes
- Medicare: Within 30 days after surgery, 1.1% of patients experienced a severe AE and 0.5% of patients experienced a minor AE
- Commercial: Within 30 days after surgery, 6 patients experienced a severe AE and 1 patient experienced a minor AE
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- Same-day discharge
- Medicare: 84% of patients were discharged on the day of surgery
- Commercial: 100% of patients were discharged on the day of surgery
- High pain management satisfaction
- Medicare: 98.3% of patients were “very much” or a “good amount” satisfied with pain management
- Commercial: 99.3% of patients were “very much” or a “good amount” satisfied with pain management
- Postsurgical opioid use
- Medicare: 84.2% of patients did not require an opioid prescription beyond the initial 7-day prescription provided at discharge*
TJA: Medicare (N=601) and commercial (N=220)
- Individualized preoperative opioid analgesia protocol
- Non-opioid analgesia protocol consisting of acetaminophen, meloxicam, or celecoxib utilized 1 week before surgery and for 6 weeks after surgery
- Spinal anesthesia
- Periarticular infiltration with EXPAREL 266 mg, bupivacaine HCl, and adjuncts
- Restricted intravenous opioids during surgery
THA: Medicare (n=308) and commercial (n=138)
- Anterior lateral femoral cutaneous nerve field block with EXPAREL 266 mg and bupivacaine HCl
TKA: Medicare (n=337) and commercial (n=113)
- Adductor canal block with bupivacaine HCl
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials
AE, adverse event; ASC, ambulatory surgery center; ERAS, enhanced recovery after surgery; THA, total hip arthroplasty; TJA, total joint arthroplasty; TKA, total knee arthroplasty.
Total Joint Arthroplasty: Freestanding ASC in Illinois22
Study Methods
- 115 adult patients undergoing total joint arthroplasty (TJA)
- 37 total hip arthroplasties (THAs)
- 53 total knee arthroscopies (TKAs)
- 25 unicompartmental knee arthroplasties (UKAs)
- Retrospective cohort review
Safety Outcomes
- There was 1 incident of a 30-day complication
- Intertrochanteric femur fracture treated with nonsurgical management
- There were 4 incidents of 90-day complications
- 2 incidents of arthrofibrosis treated with manipulation under anesthesia
- 1 incident of patellar tendon rupture during therapy treated with surgical repair
- 1 incident of hematogenous infection treated with a 2-stage exchange arthroplasty
- There were 0 incidents of intrasurgical complications, blood transfusions, hospital admissions, adverse events within the ASC, venous thromboembolisms, or readmissions for postsurgical pain
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
100% discharge rate to home for all patients
135 minutes of average recovery time for hip procedures†
132 minutes of average recovery time for knee procedures†
0 readmissions for postsurgical pain
TJA protocol (N=115)
- Presurgical regimen of celecoxib, when not contraindicated, hydrocodone or oxycodone based on the surgeon’s preference, and gabapentin
- Presurgical intravenous (IV) antibiotic administration
- General anesthesia for all patients, with regional adductor blocks for patients undergoing TKA or UKA
- Intrasurgical pericapsular injection of EXPAREL, epinephrine, morphine, bupivacaine, and ketorolac‡
- Intrasurgical IV or topical tranexamic acid based on the surgeon’s preference
- Postsurgical pain management included celecoxib, oxycodone, or hydrocodone based on the surgeon’s preference with a minimization
of IV narcotic administration
- Prophylaxis for venous thromboembolism included enteric-coated aspirin 325 mg twice per day and mobile calf pumps, warfarin,
or enoxaparin sodium based on the surgeon’s preference
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Recovery duration started with the transfer of the patient from the operating room to the postanesthesia care unit and concluded at the discharge of the patient from the ASC
‡The use of EXPAREL in combination with epinephrine is not part of the approved label
TJA, total joint arthroplasty; THA, total hip arthroplasty; TKA, total knee arthroplasty; UKA, unicondylar knee arthroplasty; ASC, ambulatory surgery center.
Total Joint Arthroplasty: Freestanding ASC in Illinois22
Study Methods
- 115 adult patients undergoing total joint arthroplasty (TJA)
- 37 total hip arthroplasties (THAs)
- 53 total knee arthroscopies (TKAs)
- 25 unicompartmental knee arthroplasties (UKAs)
- Retrospective cohort review
Safety Outcomes
- There was 1 incident of a 30-day complication
- Intertrochanteric femur fracture treated with nonsurgical management
- There were 4 incidents of 90-day complications
- 2 incidents of arthrofibrosis treated with manipulation under anesthesia
- 1 incident of patellar tendon rupture during therapy treated with surgical repair
- 1 incident of hematogenous infection treated with a 2-stage exchange arthroplasty
- There were 0 incidents of intrasurgical complications, blood transfusions, hospital admissions, adverse events within the ASC, venous thromboembolisms, or readmissions for postsurgical pain
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- 100% discharge rate to home for all patients
- 135 minutes of average recovery time for hip procedures†
- 132 minutes of average recovery time for knee procedures†
- 0 readmissions for postsurgical pain
TJA protocol (N=115)
- Presurgical regimen of celecoxib, when not contraindicated, hydrocodone or oxycodone based on the surgeon’s preference, and gabapentin
- Presurgical intravenous (IV) antibiotic administration
- General anesthesia for all patients, with regional adductor blocks for patients undergoing TKA or UKA
- Intrasurgical pericapsular injection of EXPAREL, epinephrine, morphine, bupivacaine, and ketorolac‡
- Intrasurgical IV or topical tranexamic acid based on the surgeon’s preference
- Postsurgical pain management included celecoxib, oxycodone, or hydrocodone based on the surgeon’s preference with a minimization of IV narcotic administration
- Prophylaxis for venous thromboembolism included enteric-coated aspirin 325 mg twice per day and mobile calf pumps, warfarin, or enoxaparin sodium based on the surgeon’s preference
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Recovery duration started with the transfer of the patient from the operating room to the postanesthesia care unit and concluded at the discharge of the patient from the ASC
‡The use of EXPAREL in combination with epinephrine is not part of the approved label
TJA, total joint arthroplasty; THA, total hip arthroplasty; TKA, total knee arthroplasty; UKA, unicondylar knee arthroplasty; ASC, ambulatory surgery center.
Total Joint Arthroplasty: ASC in New Jersey23
Study Methods
- 51 consecutive TJA procedures performed with the use of EXPAREL by 3 fellowship-trained adult reconstruction surgeons
- Procedures included THA, TKA, and UKA
- Retrospective review of outpatient medical records and preoperative and postsurgical clinical charts
Safety Outcomes
- All adverse events were minor and treated within the ASC without the need for overnight observation or hospitalization
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
84% of patients surveyed (n=19) reported pain level as expected and well controlled
0% of patients required an ED visit for uncontrolled pain and postsurgical transfusion
0% of patients experienced a
reported adverse event that required prolonged care or hospitalization
98% of patients were discharged to home - 1 THA patient elected to go to a rehabilitation facility prior to surgery
80% of patients surveyed (n=19) would recommend the ASC to friends and family
TJA protocol (N=51)
- Preoperative regimen: 1 dose each of celecoxib, oxycodone hydrochloride extended release, and gabapentin
- Perioperative regimen: 1 dose of intravenous acetaminophen and 2 doses of intravenous dexamethasone
- Intraoperative regimen†: Periarticular injection of EXPAREL, epinephrine, morphine, methylprednisolone, and cefazolin in 20 mL of normal saline
- Postsurgical regimen: Celecoxib, oxycodone hydrochloride extended release for 7 days, and oxycodone for breakthrough pain
THA (n=22)
- Average surgical time was 132 minutes and total LOS was 6.3 hours
- Received a lumbar epidural catheter in preoperative holding and propofol sedation intraoperatively
TKA (n=15)
- Average surgical time was 130 minutes and total LOS was 7.1 hours
- Received a single-dose femoral nerve block, a single-dose tibial nerve block, and an adductor canal catheter block in preoperative holding
UKA (n=14)
- Average surgical time was 130 minutes and total LOS was 6.2 hours
- Received a single-dose femoral nerve block, a single-dose tibial nerve block, and an adductor canal catheter block in preoperative holding
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†The use of EXPAREL in combination with epinephrine is not part of the approved label
TJA, total joint arthroplasty; TKA, total knee arthroplasty; UKA, unicondylar knee arthroplasty.
Total Joint Arthroplasty: ASC in New Jersey23
Study Methods
- 51 consecutive TJA procedures performed with the use of EXPAREL by 3 fellowship-trained adult reconstruction surgeons
- Procedures included THA, TKA, and UKA
- Retrospective review of outpatient medical records and preoperative and postsurgical clinical charts
Safety Outcomes
- All adverse events were minor and treated within the ASC without the need for overnight observation or hospitalization
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- 84% of patients surveyed (n=19) reported pain level as expected and well controlled
- 0% of patients required an ED visit for uncontrolled pain and postsurgical transfusion
- 0% of patients experienced a reported adverse event that required prolonged care or hospitalization
- 98% of patients were discharged to home
- 1 THA patient elected to go to a rehabilitation facility prior to surgery
- 80% of patients surveyed (n=19) would recommend the ASC to friends and family
TJA protocol (N=51)
- Preoperative regimen: 1 dose each of celecoxib, oxycodone hydrochloride extended release, and gabapentin
- Perioperative regimen: 1 dose of intravenous acetaminophen and 2 doses of intravenous dexamethasone
- Intraoperative regimen†: Periarticular injection of EXPAREL, epinephrine, morphine, methylprednisolone, and cefazolin in 20 mL of normal saline
- Postsurgical regimen: Celecoxib, oxycodone hydrochloride extended release for 7 days, and oxycodone for breakthrough pain
THA (n=22)
- Average surgical time was 132 minutes and total LOS was 6.3 hours
- Received a lumbar epidural catheter in preoperative holding and propofol sedation intraoperatively
TKA (n=15)
- Average surgical time was 130 minutes and total LOS was 7.1 hours
- Received a single-dose femoral nerve block, a single-dose tibial nerve block, and an adductor canal catheter block in preoperative holding
UKA (n=14)
- Average surgical time was 130 minutes and total LOS was 6.2 hours
- Received a single-dose femoral nerve block, a single-dose tibial nerve block, and an adductor canal catheter block in preoperative holding
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†The use of EXPAREL in combination with epinephrine is not part of the approved label
TJA, total joint arthroplasty; TKA, total knee arthroplasty; UKA, unicondylar knee arthroplasty.
Total Knee Arthroplasty: 16 US Centers24
Study Methods
- 139 patients who received a TKA, with 70 receiving EXPAREL and 69 who did not
- Phase 4 clinical trial
Safety Outcomes
- Both treatments were well tolerated, with most adverse events mild or moderate. One patient in each group experienced a serious adverse event, with both events deemed unrelated to the study medication
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Significantly better pain control (P=0.0381) 12 to 48 hours after surgery†
78% reduction in opioid use 0 to 48 hours after surgery (P=0.0048)*
10% of patients free of opioids at 72 hours (P<0.01)‡
TKA protocol (N=139)
- Preoperative regimen: Acetaminophen 1000 mg, celecoxib 200 mg, oral pregabalin 300 mg, and intravenous tranexamic acid 1 g within 4 hours before surgery
- Intraoperative regimen: Fentanyl or its analogs
- Postsurgical regimen: Oral acetaminophen 975 to 1000 mg every 8 hours, oral celecoxib 200 mg every 12 hours, rescue analgesics as needed (oral immediate-release oxycodone ≤10 mg every 4 hours or as needed, intravenous morphine 2.5 to 5 mg or hydromorphone 0.5 to 1 mg every 4 hours or as needed if oral medication was not tolerated). Rescue medications were received upon patient request for analgesia
TKA with EXPAREL (n=70)
- Local infiltration with EXPAREL 266 mg/20 mL admixed with bupivacaine HCl 0.5%, 20 mL, expanded with saline to a total volume of 120 mL
TKA without EXPAREL (n=69)
- Local infiltration with bupivacaine HCl 0.5%, 20 mL, expanded with saline to a total volume of 120 mL
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Pain measured using visual analog scale
‡Compared with 0% of patients who received bupivacaine HCl alone
TKA, total knee arthroplasty.
Total Knee Arthroplasty: 16 US Centers24
Study Methods
- 139 patients who received a TKA, with 70 receiving EXPAREL and 69 who did not
- Phase 4 clinical trial
Safety Outcomes
- Both treatments were well tolerated, with most adverse events mild or moderate. One patient in each group experienced a serious adverse event, with both events deemed unrelated to the study medication
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- Significantly better pain control (P=0.0381) 12 to 48 hours after surgery†
- 78% reduction in opioid use 0 to 48 hours after surgery (P=0.0048)*
- 10% of patients free of opioids at 72 hours (P<0.01)‡
TKA protocol (N=139)
- Preoperative regimen: Acetaminophen 1000 mg, celecoxib 200 mg, oral pregabalin 300 mg, and intravenous tranexamic acid 1 g within 4 hours before surgery
- Intraoperative regimen: Fentanyl or its analogs
- Postsurgical regimen: Oral acetaminophen 975 to 1000 mg every 8 hours, oral celecoxib 200 mg every 12 hours, rescue analgesics as needed (oral immediate-release oxycodone ≤10 mg every 4 hours or as needed, intravenous morphine 2.5 to 5 mg or hydromorphone 0.5 to 1 mg every 4 hours or as needed if oral medication was not tolerated). Rescue medications were received upon patient request for analgesia
TKA with EXPAREL (n=70)
- Local infiltration with EXPAREL 266 mg/20 mL admixed with bupivacaine HCl 0.5%, 20 mL, expanded with saline to a total volume of 120 mL
TKA without EXPAREL (n=69)
- Local infiltration with bupivacaine HCl 0.5%, 20 mL, expanded with saline to a total volume of 120 mL
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†Pain measured using visual analog scale
‡Compared with 0% of patients who received bupivacaine HCl alone
TKA, total knee arthroplasty.
Total Shoulder Arthroplasty or Rotator Cuff Repair: 16 International Study Sites25
Study Methods
- 140 patients undergoing TSA or RCR who received EXPAREL (n=69) or placebo (n=71)
- Phase 3 clinical trial
Safety Outcomes
- 4 patients (3 in the EXPAREL group and 1 in the placebo group) experienced adverse events that were deemed unrelated to the study medication
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Significantly better pain control (P<0.0001) through 48 hours after surgery- Median time to return of sensory function with EXPAREL was 36 hours, which was significantly longer than placebo (P<0.0001), and median time to return of motor function was 24 hours with both EXPAREL and placebo
78% reduction in opioid use through 48 hours (P<0.0001)*
13% of patients
opioid-free compared with 1% with placebo at 48 hours (P=0.008)
TSA or RCR
- Preoperative regimen
- Low-dose aspirin for cardioprotection and oral or intravenous acetaminophen 1000 mg every 8 hours
- Patients randomized 1:1:1 to EXPAREL 266 mg, EXPAREL 133 mg, or matching placebo (20 mL total volume for each). Randomization to EXPAREL 266 mg stopped after sufficient patients (n=15) were selected for pharmacokinetic assessment
- Postsurgical regimen
- Rescue medication only given based on patient request
- Oral immediate-release oxycodone ≤10 mg every 4 hours or as needed and intravenous morphine 2.5 to 5 mg or hydromorphone 0.5 to 1 mg every 4 hours or as needed if oral medication was not tolerated
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
RCR, rotator cuff repair; TSA, total shoulder arthroplasty.
Total Shoulder Arthroplasty or Rotator Cuff Repair: 16 International Study Sites25
Study Methods
- 140 patients undergoing TSA or RCR who received EXPAREL (n=69) or placebo (n=71)
- Phase 3 clinical trial
Safety Outcomes
- 4 patients (3 in the EXPAREL group and 1 in the placebo group) experienced adverse events that were deemed unrelated to the study medication
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
- Significantly better pain control (P<0.0001) through 48 hours after surgery
- Median time to return of sensory function with EXPAREL was 36 hours, which was significantly longer than placebo (P<0.0001), and median time to return of motor function was 24 hours with both EXPAREL and placebo
- 78% reduction in opioid use through 48 hours (P<0.0001)*
- 13% of patients opioid-free compared with 1% with placebo at 48 hours (P=0.008)
TSA or RCR
- Preoperative regimen
- Low-dose aspirin for cardioprotection and oral or intravenous acetaminophen 1000 mg every 8 hours
- Patients randomized 1:1:1 to EXPAREL 266 mg, EXPAREL 133 mg, or matching placebo (20 mL total volume for each). Randomization to EXPAREL 266 mg stopped after sufficient patients (n=15) were selected for pharmacokinetic assessment
- Postsurgical regimen
- Rescue medication only given based on patient request
- Oral immediate-release oxycodone ≤10 mg every 4 hours or as needed and intravenous morphine 2.5 to 5 mg or hydromorphone 0.5 to 1 mg every 4 hours or as needed if oral medication was not tolerated
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
RCR, rotator cuff repair; TSA, total shoulder arthroplasty.
Shoulder Arthroplasty: Hospital in Florida26
Study Methods
- 55 patients undergoing SA who received a standardized multimodal pain management approach alone (n=24) or a standardized multimodal pain management approach with EXPAREL and dexamethasone (n=31)
- Retrospective cohort analysis
Clinical and Economic Outcomes
Patients who received EXPAREL and dexamethasone for analgesia had
Significantly less pain (P<0.001) on POD 1
51% less cumulative opioid use for all PODs (P<0.001)*
50% reduction
in LOS (P<0.001)
SA (N=55)
- Preoperative
- Single-injection interscalene block with 1000 mg of intravenous acetaminophen, 600 mg of oral gabapentin, 10 mg of oral oxycodone, and 200 mg of oral celecoxib
- Postsurgical
- Intravenous ketorolac and acetaminophen with oral gabapentin for 24 hours after surgery
- 5 mg and 10 mg of oxycodone for mild to moderate pain and 0.5 mg, 1 mg, and 2 mg of intravenous hydromorphone for moderate to severe pain
SA with EXPAREL and dexamethasone (n=31)
- Intraoperative
- Intravenous administration of 8 to 10 mg of dexamethasone and injection of 50 mL admixture of saline, 0.25% bupivacaine HCl with epinephrine, and EXPAREL. 20 mL of EXPAREL was diluted with 20 mL of saline and 10 mL of 0.25% bupivacaine HCl with epinephrine†
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†The use of EXPAREL in combination with epinephrine is not part of the approved label
POD, postoperative day; SA, shoulder arthroplasty; LOS, length of stay.
Shoulder Arthroplasty: Hospital in Florida26
Study Methods
- 55 patients undergoing SA who received a standardized multimodal pain management approach alone (n=24) or a standardized multimodal pain management approach with EXPAREL and dexamethasone (n=31)
- Retrospective cohort analysis
Clinical and Economic Outcomes
Patients who received EXPAREL and dexamethasone for analgesia had
- Significantly less pain (P<0.001) on POD 1
- 51% less cumulative opioid use for all PODs (P<0.001)*
- 50% reduction in LOS (P<0.001)
SA (N=55)
- Preoperative
- Single-injection interscalene block with 1000 mg of intravenous acetaminophen, 600 mg of oral gabapentin, 10 mg of oral oxycodone, and 200 mg of oral celecoxib
- Postsurgical
- Intravenous ketorolac and acetaminophen with oral gabapentin for 24 hours after surgery
- 5 mg and 10 mg of oxycodone for mild to moderate pain and 0.5 mg, 1 mg, and 2 mg of intravenous hydromorphone for moderate to severe pain
SA with EXPAREL and dexamethasone (n=31)
- Intraoperative
- Intravenous administration of 8 to 10 mg of dexamethasone and injection of 50 mL admixture of saline, 0.25% bupivacaine HCl with epinephrine, and EXPAREL. 20 mL of EXPAREL was diluted with 20 mL of saline and 10 mL of 0.25% bupivacaine HCl with epinephrine†
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials
†The use of EXPAREL in combination with epinephrine is not part of the approved label
POD, postoperative day; SA, shoulder arthroplasty; LOS, length of stay.
How to Order
Opening an Account & How to Order EXPAREL
EXPAREL NDC Codes
The 133 mg (10 mL) and 266 mg (20 mL) Doses of EXPAREL are Now Available in Cartons of 4 and 10 vials
As of March 20, 2017, there are 4 SKUs of EXPAREL available.
NDC # | Dose/vial size | Configuration |
---|---|---|
65250-266-09 | EXPAREL 266 mg/20 mL | Carton of 10 vials |
65250-266-04 | EXPAREL 266 mg/20 mL | Carton of 4 vials |
65250-133-09 | EXPAREL 133 mg/10 mL | Carton of 10 vials |
65250-133-04 | EXPAREL 133 mg/10 mL | Carton of 4 vials |
NDC, National drug code.
For First-Time Orders
- You must have an account with Pacira to make direct orders. If you do not have an account, fill out a Letter of Affiliation
- Fax the form to (855) 803-9481 with
- A copy of your facility license
- A business card or letterhead displaying the same address
Note: This should be done immediately before calling to place an order.
- If you are practicing in the state of Florida, you will also need to fill out and submit the Health Care Clinic Establishment form
- All purchases are subject to Pacira's General Terms & Conditions and Return Goods Policy

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