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EXPAREL in Orthopedics

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 total shoulder arthroplasty and rotator cuff repair

EXPAREL vs placebo in ISBP nerve block for total shoulder arthroplasty and rotator cuff repair study1*

See the full study

78% FEWER OPIOIDS overall opioid consumption (P<0.0001)

Significantly better pain control cumulative pain scores (P<0.0001)

Results from a phase 3, multicenter, controlled trial that compared the postsurgical analgesia efficacy, safety, and pharmacokinetics of EXPAREL 133 mg (10 mL) and placebo in patients undergoing total shoulder arthroplasty or rotator cuff repair. Primary and secondary end points: pain intensity through 48 hours postsurgery, as measured by AUC of VAS pain intensity scores, and total postsurgical opioid consumption.

AUC, area under the curve; ISBP, interscalene brachial plexus; VAS, Visual Analogue Scale.

*Rescue opioids for pain were available upon patient request.

Dosing for local infiltration & regional analgesia

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

Dosing for regional analgesia

For interscalene brachial plexus nerve block in adults, the recommended dose is 133 mg (10 mL), based on a study of patients undergoing rotator cuff repair or total shoulder arthroplasty

For adductor canal block in adults, the recommended dose is 133 mg (10 mL) admixed with 50 mg (10 mL) 0.5% bupivacaine HCl, for a total volume of 20 mL, based on a study of patients undergoing total knee arthroplasty

For sciatic nerve block in the popliteal fossa in adults, the recommended dose is 133 mg (10 mL), based on a study of patients undergoing bunionectomy

Admixing bupivacaine HCl with 133 mg (10 mL) of EXPAREL

  • One 10 mL vial contains 133 mg of EXPAREL, which is equivalent to 150 mg of bupivacaine HCl
  • 1:2 ratio allows up to 75 mg of bupivacaine HCI to 133 mg of EXPAREL
Expansion Techniques
Administration Guidance
dosing 266

Multimodal protocols and results

Multimodal approaches with or without ERAS protocols have demonstrated benefits in shoulder surgery

Study design2

Retrospective study comparing the efficacy of EXPAREL and dexamethasone intraoperatively as part of multimodal pain management (n=31) versus standard multimodal pain management (n=24) in patients undergoing elective shoulder arthroplasty.

Multimodal protocol

PREOPERATIVE

INTRAOPERATIVE

POSTSURGICAL

PREOPERATIVE

  • Single-injection interscalene block
    • Acetaminophen 1000 mg intravenously
    • Gabapentin 600 mg orally
    • Oxycodone 10 mg orally
    • Celecoxib 200 mg orally

INTRAOPERATIVE

  • Standard multimodal group: none
  • EXPAREL group:
    • EXPAREL 266 mg/20 mL + saline 20 mL + 0.25% bupivacaine HCl with epinephrine 10 mL*
    • Dexamethasone 8 to 10 mg intravenously

POSTSURGICAL

  • Ketorolac intravenously
  • Acetaminophen intravenously
  • Gabapentin orally
  • Oxycodone 5 mg and 10 mg orally for mild to moderate pain
  • Hydromorphone 0.5 mg, 1 mg, and 2 mg intravenously for moderate to severe pain

Patients who received multimodal analgesia with EXPAREL

Lower pain level
  • 3.5 vs 7.5 VAS pain score on POD 1 (P<0.001)
Fewer opioids used in PACU*†
  • 20 mg vs 40.5 mg in cumulative utilization (P<0.001)
Shorter LOS
  • 1 day vs 2 days (P<0.001)

*The use of EXPAREL in combination with epinephrine is not part of the approved label.

†Opioid intake measured in MED (mg).

LOS, length of stay; MED, morphine equivalent dosing; POD, postoperative day; VAS, visual analog scale.

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. Patel MA, Gadsden JC, Nedeljkovic SS, et al. Brachial plexus block with liposomal bupivacaine for shoulder surgery improves analgesia and reduces opioid consumption: results from a multicenter, randomized, double-blind, controlled trial. Pain Med. 2020;21(2):387-400.
  2. Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017;26(4):641-647.
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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