EXPAREL Provides Pain Relief When It Matters Most

EXPAREL in Colorectal/General Surgery

Clinical Efficacy

Manage Pain & Minimize Opioids After Hemorrhoidectomy

EXPAREL vs placebo in hemorrhoidectomy^1,2

Significantly Lower Opioid Use*

45% lower overall opioid consumption (P=0.0006)^†

Significantly Better Pain Control

30% lower cumulative pain scores (P<0.0001)^†

Study Design

*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials.

^†Results vs placebo through 72 hours. Opioid reduction calculated based on geometric mean ratio.

AUC, area under the curve.

Clinical & Economic Outcomes

EXPAREL is a cost-effective option for postsurgical pain management both in the hospital and in outpatient settings

*Pain was measured using the visual analog scale (0 to 10)³

^†The clinical benefit of the decrease in opioid consumption was not demonstrated in pivotal trials. 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])³

^‡Costs were defined as the actual per-patient total costs for the entire inpatient episode³

Laparoscopic  Colorectal Surgery³

Medical center in Texas

Significantly better pain control  (P=0.001) in the PACU*
65% fewer opioids consumed over 3 days^†
1 day shorter LOS
$746 lower overall costs to the hospital^‡

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*Pain was measured using the visual analog scale (0 to 10)³

^‡Costs were defined as the actual per-patient total costs for the entire inpatient episode³

Multimodal Protocols & Results

Multimodal approaches with or without ERAS protocols have demonstrated benefits in colorectal and general surgeries

Abdominal Wall Reconstruction

Laparoscopic Colorectal Surgery

Open Ventral Hernia Repair

Laparoscopic Donor Nephrectomy

Multimodal Protocol

Multimodal pain control	Acceleration of intestinal recovery
Intraoperative TAP block with EXPAREL 266 mg/20 mL expanded to 120 mL with normal saline Hydromorphone HCl PCA of 0.2 mg every 6 minutes until able to administer orally Acetaminophen 1000 mg intravenously every 6 hours for 48 hours; transition  to acetaminophen 650 mg orally every  6 hours, along with oxycodone 5 to 10 mg orally every 4 hours as needed	Gabapentin 300 mg orally 3 times daily until discharge Diazepam 5 mg intravenously every 6 hours for 48 hours; hold for obstructive sleep apnea and one-half dose for patients aged >65 years NSAIDs as needed, starting 48 hours postsurgically, with  a hold for patients with any renal dysfunction Minimization of opioids through multimodal pain control Alvimopan 12 mg orally preoperatively in the holding area and every 12 hours postsurgically until discharge or POD 7

Multimodal pain control

Acceleration of intestinal recovery

Intraoperative TAP block with EXPAREL 266 mg/20 mL expanded to 120 mL with normal saline
Hydromorphone HCl PCA of 0.2 mg every 6 minutes until able to administer orally
Acetaminophen 1000 mg intravenously every 6 hours for 48 hours; transition  to acetaminophen 650 mg orally every  6 hours, along with oxycodone 5 to 10 mg orally every 4 hours as needed

Gabapentin 300 mg orally 3 times daily until discharge
Diazepam 5 mg intravenously every 6 hours for 48 hours; hold for obstructive sleep apnea and one-half dose for patients aged >65 years
NSAIDs as needed, starting 48 hours postsurgically, with  a hold for patients with any renal dysfunction
Minimization of opioids through multimodal pain control
Alvimopan 12 mg orally preoperatively in the holding area and every 12 hours postsurgically until discharge or POD 7

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Multimodal pain control

Intraoperative TAP block with EXPAREL 266 mg/20 mL expanded to 120 mL with normal saline
Hydromorphone HCl PCA of 0.2 mg every 6 minutes until able to administer orally
Acetaminophen 1000 mg intravenously every 6 hours for 48 hours; transition to acetaminophen 650 mg orally every 6 hours, along with oxycodone 5 to 10 mg orally every 4 hours as needed

Acceleration of intestinal recovery

Gabapentin 300 mg orally 3 times daily until discharge
Diazepam 5 mg intravenously every 6 hours for 48 hours; hold for obstructive sleep apnea and one-half dose for patients aged >65 years
NSAIDs as needed, starting 48 hours postsurgically, with a hold for patients with any renal dysfunction
Minimization of opioids through multimodal pain control
Alvimopan 12 mg orally preoperatively in the holding area and every 12 hours postsurgically until discharge or POD 7

Patients Who Received Multimodal Analgesia With EXPAREL

Faster Return to Bowel Function

3.6 days vs 5.0 days (P<0.0001)

Shorter LOS

4.4 days vs 5.8 days (P<0.0001)

Study Design⁴

ERAS, enhanced recovery after surgery; LOS, length of stay; NSAID; non-steroidal anti-inflammatory drug; PCA, patient-controlled analgesia; POD, postoperative day; TAP, transversus abdominis plane.

Multimodal Protocol

Preoperative	Intraoperative	Postsurgical
Gabapentin 300 mg orally the night before surgery and 2 hours before surgery Celecoxib 400 mg orally 2 hours before surgery	Dexamethasone 8 mg and acetaminophen 1000 mg intravenously at induction of anesthesia Ketorolac 30 mg intravenously 30 minutes before emergence from anesthesia Acetaminophen 1000 mg intravenously 30 minutes before emergence from anesthesia EXPAREL group: local infiltration at port sites with EXPAREL 266 mg/20 mL expanded with normal saline 20 mL and 0.25% regular bupivacaine 20 mL	Acetaminophen 1000 mg every 6 hours intravenously until oral form is tolerated, then transitioned to 650 mg orally every 6 hours Ketorolac scheduled 30 mg intravenously every 6 hours for 48 hours, followed by celecoxib 400 mg orally twice daily Gabapentin 300 mg orally every 8 hours Oxycodone 5 to 10 mg orally every 6 hours as needed for breakthrough pain intensity of  4 to 8 on a scale of 10 Hydromorphone HCl 0.4 to  0.6 mg intravenously every  2 hours as needed for breakthrough pain intensity  of 8 to 10 on a scale of 10

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Preoperative

Gabapentin 300 mg orally the night before surgery and 2 hours before surgery
Celecoxib 400 mg orally 2 hours before surgery

Intraoperative

Dexamethasone 8 mg and acetaminophen 1000 mg intravenously at induction of anesthesia
Ketorolac 30 mg intravenously 30 minutes before emergence from anesthesia
Acetaminophen 1000 mg intravenously 30 minutes before emergence from anesthesia
EXPAREL group: local infiltration at port sites with EXPAREL 266 mg/ 20 mL expanded with normal saline 20 mL and 0.25% regular bupivacaine 20 mL

Postsurgical

Acetaminophen 1000 mg every  6 hours intravenously until oral form is tolerated, then transitioned to 650 mg orally every 6 hours
Ketorolac scheduled 30 mg intravenously every 6 hours for 48 hours, followed by celecoxib 400 mg orally twice daily
Gabapentin 300 mg orally every 8 hours
Oxycodone 5 to 10 mg orally every 6 hours as needed for breakthrough pain intensity of 4 to 8 on a scale of 10
Hydromorphone HCl 0.4 to 0.6 mg intravenously every 2 hours as needed for breakthrough pain intensity of 8 to 10 on a scale of 10

Patients Who Received Multimodal Analgesia With EXPAREL

Lower Mean Pain Scores in PACU

1.92 vs 4.71 (P=0.001)

Fewer Opioids Used in PACU*^†

1.16 vs 3.56 (P<0.01)

Shorter
LOS*^†

2.96 days vs 3.93 days (P=0.003)

Study Design³

*Opioid use was measured by the defined daily dose, with 1 unit equaling 100 mcg of intravenous fentanyl, 2 mg of intravenous hydromorphone HCl, 4 mg of oral hydromorphone HCl, 20 mg of oral oxycodone, or 10 mg of oral hydrocodone

^†The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials

ERP, enhanced recovery pathway; ERAS, enhanced recovery after surgery; LOS, length of stay; PACU, postanesthesia care unit; TAP, transversus abdominis plane.

Multimodal Protocol

	Preoperative	Intraoperative	Postsurgical
ERAS	Alvimopan 12 mg orally Gabapentin 100  to 300 mg orally	Minimization of opioids and paralytics Intraoperative TAP  block with EXPAREL  266 mg/20 mL expanded to 200 mL (100 mL per side)	Hydromorphone intravenously in PCA: 0.2 mg every 6 to 10 minutes with no breakthrough dose or basal rate; stopped on POD 2 once on clear liquids Oxycodone 5 to 10 mg orally every 4 hours as needed once off intravenous PCA Acetaminophen 650 mg orally every 6 hours immediately after surgery Gabapentin 100 to 300 mg orally every 6 hours 3 times daily starting on POD 1 Diazepam 5 mg intravenously every 6 hours as needed; 2.5 mg for patients >65 years old. Not used for patients with OSA, sedation, or any respiratory compromise NSAID 600 to 800 mg orally every 6 to 8 hours as needed; held for patients with renal dysfunction and substituted with ketorolac 15 to 30 mg intravenously every 6 hours
Without ERAS		Opioids and/or paralytics per anesthesia	Hydromorphone intravenously in PCA: 0.2 mg every 6 minutes, 0.6 mg/hr breakthrough or basal rate as needed until tolerating full liquids or regular diet Oxycodone 5 to 10 mg orally every 4 hours as needed once tolerating full liquids and/or regular diet Acetaminophen 650 to 975 mg orally as needed once tolerating oral intake Diazepam 5 mg intravenously every 6 hours

Preoperative

Intraoperative

Postsurgical

ERAS

Alvimopan 12 mg orally
Gabapentin 100  to 300 mg orally

Minimization of opioids and paralytics

Intraoperative TAP  block with EXPAREL  266 mg/20 mL expanded to 200 mL (100 mL per side)

Hydromorphone intravenously in PCA: 0.2 mg every 6 to 10 minutes with no breakthrough dose or basal rate; stopped on POD 2 once on clear liquids
Oxycodone 5 to 10 mg orally every 4 hours as needed once off intravenous PCA
Acetaminophen 650 mg orally every 6 hours immediately after surgery
Gabapentin 100 to 300 mg orally every 6 hours 3 times daily starting on POD 1
Diazepam 5 mg intravenously every 6 hours as needed; 2.5 mg for patients >65 years old. Not used for patients with OSA, sedation, or any respiratory compromise
NSAID 600 to 800 mg orally every 6 to 8 hours as needed; held for patients with renal dysfunction and substituted with ketorolac 15 to 30 mg intravenously every 6 hours

Without ERAS

Opioids and/or paralytics per anesthesia

Hydromorphone intravenously in PCA: 0.2 mg every 6 minutes, 0.6 mg/hr breakthrough or basal rate as needed until tolerating full liquids or regular diet
Oxycodone 5 to 10 mg orally every 4 hours as needed once tolerating full liquids and/or regular diet
Acetaminophen 650 to 975 mg orally as needed once tolerating oral intake
Diazepam 5 mg intravenously every 6 hours

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With ERAS

Preoperative

Alvimopan 12 mg orally
Gabapentin 100 to 300 mg orally

Intraoperative

Minimization of opioids and paralytics
Intraoperative TAP block with EXPAREL 266 mg/20 mL expanded to 200 mL (100 mL per side)

Postsurgical

Hydromorphone intravenously in PCA: 0.2 mg every 6 to 10 minutes with no breakthrough dose or basal rate; stopped on POD 2 once on clear liquids
Oxycodone 5 to 10 mg orally every 4 hours as needed once off intravenous PCA
Acetaminophen 650 mg orally every 6 hours immediately after surgery
Gabapentin 100 to 300 mg orally every 6 hours 3 times daily starting on POD 1
Diazepam 5 mg intravenously every 6 hours as needed; 2.5 mg for patients >65 years old. Not used for patients with OSA, sedation, or any respiratory compromise
NSAID 600 to 800 mg orally every  6 to 8 hours as needed; held for patients with renal dysfunction and substituted with ketorolac 15 to 30 mg intravenously every 6 hours

Without ERAS

Intraoperative

Opioids and/or paralytics per anesthesia

Postsurgical

Hydromorphone intravenously in PCA: 0.2 mg every 6 minutes, 0.6 mg/hr breakthrough or basal rate as needed until tolerating full liquids or regular diet
Oxycodone 5 to 10 mg orally every 4 hours as needed once tolerating full liquids and/or regular diet
Acetaminophen 650 to 975 mg orally as needed once tolerating oral intake
Diazepam 5 mg intravenously every 6 hours

Patients Who Received Multimodal Analgesia With EXPAREL

Shorter Time to Liquids & Regular Diet

Liquid: 1.1 days vs 2.7 days (P<0.001)

Regular: 3.0 days vs 4.8 days (P<0.001)

Shorter Time to Flatus & Bowel Movement

Flatus: 3.1 days vs 3.9 days (P<0.001)
Bowel movement: 3.6 days vs 5.2 days (P<0.001)

Fewer 90-day Readmissions

4% vs 16% (P=0.008)

Study Design⁵

ERAS, enhanced recovery after surgery; NSAID, nonsteroidal anti-inflammatory drug; OSA, obstructive sleep apnea; PCA, patient-controlled anesthesia; POD, postoperative day.

Multimodal Protocol

Preoperative	Intraoperative	Postsurgical
Acetaminophen 975 mg orally Gabapentin 600 mg orally	Fentanyl boluses Subfascial EXPAREL Dexamethasone 4 mg intravenously at start of case Acetaminophen 1000 mg intravenously toward end  of case Ketorolac 15 mg intravenously toward end of case	Acetaminophen orally Ketorolac intravenously within first 24 hours Gabapentin orally Tramadol orally as needed

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Preoperative

Acetaminophen 975 mg orally
Gabapentin 600 mg orally

Intraoperative

Fentanyl boluses
Subfascial EXPAREL
Dexamethasone 4 mg intravenously at start of case
Acetaminophen 1000 mg intravenously toward end of case
Ketorolac 15 mg intravenously toward end of case

Postsurgical

Acetaminophen orally
Ketorolac intravenously within first 24 hours
Gabapentin orally
Tramadol orally as needed

Patients Who Received Multimodal Analgesia With EXPAREL

Decreased Pain Scores Morning After Surgery

3 vs 7 (P<0.001)

Shorter

LOS

1 day vs 2 days (P<0.001)

Study Design⁶

ERAS, enhanced recovery after surgery; LOS, length of stay.

Societies Recommend Opioid-Minimizing Pain Management Platforms

Leading medical societies recommend opioid-minimizing pain management strategies to enhance recovery after colorectal and general surgeries procedures

ERAS
Colorectal Surgery 2018
Strong recommendation for the use of TAP blocks for minimally invasive colorectal surgery, noting that shorter acting local anesthetics have limited duration. Liposomal bupivacaine is included as an alternative to extend the duration.⁷
ERAS, enhanced recovery after surgery.

ASCRS and SAGES
Colorectal Surgery 2016
Strong recommendation for the use of perisurgical multimodal, opioid-sparing, pain management plan, noting that liposomal bupivacaine wound infiltration and transversus abdominis plane (TAP) blocks ‘have shown promising results in patients undergoing open and laparoscopic colorectal surgery.’⁸
ASCRS, American Society of Colon and Rectal Surgeons; SAGES, Society of American Gastrointestinal Endoscopic Surgeons.

Related Resources

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Adductor Canal Block TKA Clinical Study

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Sciatic Nerve Block in the Popliteal Fossa Study Summary

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EXPAREL vs Bupivacaine

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References

Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552-1559.
Data on File. 2363. Parsippany, NJ: Pacira BioSciences, Inc.; June 2017.
Keller DS, Pedraza R, Tahilramani RN, Flores-Gonzalez JR, Ibarra S, Haas EM. Impact of long-acting local anesthesia on clinical and financial outcomes in laparoscopic colorectal surgery. Am J Surg. 2017;214(1):53-58.
Fayezizadeh M, Petro CC, Rosen MJ, Novitsky YW. Enhanced recovery after surgery pathway for abdominal wall reconstruction: pilot study and preliminary outcomes. Plast Reconstr Surg. 2014;134(4 suppl 2):151S-159S.
Majumder A, Fayezizadeh M, Neupane R, Elliott HL, Novitsky YW. Benefits of multimodal enhanced recovery pathway in patients undergoing open ventral hernia repair. J Am Coll Surg. 2016;222(6):1106-1115.
Rege A, Leraas H, Vikraman D, et al. Could the use of an enhanced recovery protocol in laparoscopic donor nephrectomy be an incentive for live kidney donation? Cureus. 2016;8(11):e889.
Gustafsson UO, Scott MJ, Hubner M, et al. Guidelines for Perioperative care in elective colorectal surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations: 2018. World J Surg. 2019;43(3):659-695.
Carmichael JC, Keller DS, Baldini G, et al. Clinical practice guidelines for enhanced recovery after colon and rectal surgery from the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017;60(8):761-784.

EXPAREL Provides Pain Relief When It Matters Most

EXPAREL in Colorectal/General Surgery

Clinical Efficacy

Manage Pain & Minimize Opioids After Hemorrhoidectomy

Significantly Lower Opioid Use*

Significantly Better Pain Control

Clinical & Economic Outcomes

Laparoscopic Colorectal Surgery3

Multimodal Protocols & Results

Multimodal Protocol

Patients Who Received Multimodal Analgesia With EXPAREL

Faster Return to Bowel Function

Shorter LOS

Multimodal Protocol

Patients Who Received Multimodal Analgesia With EXPAREL

Lower Mean Pain Scores in PACU

Fewer Opioids Used in PACU*†

ShorterLOS*†

Multimodal Protocol

Patients Who Received Multimodal Analgesia With EXPAREL

Shorter Time to Liquids & Regular Diet

Shorter Time to Flatus & Bowel Movement

Fewer 90-day Readmissions

Multimodal Protocol

Patients Who Received Multimodal Analgesia With EXPAREL

Decreased Pain Scores Morning After Surgery

Shorter

LOS

Societies Recommend Opioid-Minimizing Pain Management Platforms

ERAS

ASCRS and SAGES

Related Resources

Laparoscopic  Colorectal Surgery³

Fewer Opioids Used in PACU*^†

Shorter
LOS*^†