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days to go: ASP+6% CMS reimbursement for proven non-opioids used in all outpatient surgical settings is coming January 1, 2025.

Clinical efficacy

Manage pain and minimize opioids after hemorrhoidectomy

EXPAREL vs placebo in hemorrhoidectomy1,2

See the full study

Significantly lower opioid use* 45% lower overall opioid consumption (P=0.0006)†

Significantly better pain control 30% lower cumulative pain scores (P<0.0001)†

Results from a phase 3, multicenter, randomized double-blind, placebo-controlled trial that evaluated the efficacy of 166 mg (20 mL) of EXPAREL in 186 patients undergoing 2- or 3-column excisional hemorrhoidectomy. Primary end point: cumulative pain score reflected in the AUC of numeric rating scale through 72 hours. Placebo was preservative-free saline for injection. Opioid rescue medication (up to 10 mg) of morphine administered intramuscularly was available to all patients.

AUC, area under the curve.

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

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

Dosing for local infiltration

Dosing for local infiltration

For adults, a maximum dose of 266 mg (20 mL) is recommended, based on:

  • Size of the surgical site
  • Volume required to cover the area
  • Individual patient factors that may impact the safety of an amide local anesthetic

For pediatric patients aged 6 to less than 17 years, dosing is weight based: 4 mg/kg (up to a maximum of 266 mg)

Admixing bupivacaine HCl with 266 mg (20 mL) of EXPAREL

  • 20 mL vial contains 266 mg of EXPAREL, which is equivalent to 300 mg of bupivacaine HCl
  • 1:2 ratio allows 150 mg of bupivacaine HCl to 266 mg of EXPAREL
Expansion Techniques
Administration Guidance
dosing 266

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 a 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 episode.3

Multimodal protocols and results

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

Abdominal Wall Reconstruction

Study design4

Analysis comparing the efficacy of an ERAS protocol that included a TAP block with EXPAREL (n=42) compared with previously used standard of care.

Multimodal protocol

MULTIMODAL PAIN CONTROL

ACCELERATION OF INTESTINAL RECOVERY

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)

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.

Study design3

Retrospective trial comparing patients receiving local infiltration of EXPAREL (n=70) as part of an ERP with those being placed in an ERP (n=70).

Multimodal protocol

PREOPERATIVE

INTRAOPERATIVE

POSTSURGICAL

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)

*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.

Study design5

Retrospective, observational study comparing patients who received an ERAS protocol with EXPAREL (n=100) with a historical group prior to the introduction of the protocol (n=100).

Multimodal protocol

PERIOPERATIVE

INTRAOPERATIVE

POSTSURGICAL

ERAS

PERIOPERATIVE

  • 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

PREOPERATIVE

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 and 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 and 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)

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

Study design6

Retrospective analysis comparing live kidney donors undergoing a laparoscopic nephrectomy under an ERAS protocol with EXPAREL (n=39) with live kidney donors under standard of care (n=40).

Multimodal protocol

PREOPERATIVE

INTRAOPERATIVE

POSTSURGICAL

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)

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

ASCRS, American Society of Colon and Rectal Surgeons; ERAS, enhanced recovery after surgery; SAGES, Society of American Gastrointestinal Endoscopic Surgeons.

ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.

Important Notice

Indication

EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.

Important Safety Information

  • EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
  • Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via nerve block were nausea, pyrexia, headache, and constipation.
  • Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.
  • Do not admix lidocaine or other non-bupivacaine local anesthetics with EXPAREL. EXPAREL may be administered at least 20 minutes or more following local administration of lidocaine.
  • EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for nerve blocks, and/or pregnant patients.
  • Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.

Warnings and Precautions Specific to EXPAREL

  • Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
  • EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block, or intravascular or intra-articular use.
  • The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.

Warnings and Precautions for Bupivacaine-Containing Products

  • Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.
  • Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death.
  • Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.
  • Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.
  • Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.

Please refer to full Prescribing Information.

References

  1. 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.
  2. Data on File. 2363. Parsippany, NJ: Pacira BioSciences, Inc.; June 2017.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
SEE MORE

EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.

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