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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 foot and ankle surgery

EXPAREL vs bupivacaine HCI in foot and ankle surgery (sciatic nerve block in the popliteal fossa pivotal trial)1

See the full study

Superior PAIN CONTROL vs bupivacaine HCI cumulative pain scores (P<0.00001)

61% fewer opioids* total postsurgical opioid consumption (P<0.00001)

The sciatic nerve block in the popliteal fossa pivotal trial investigated EXPAREL versus bupivacaine HCl administered via sciatic nerve block in the popliteal fossa in participants undergoing bunionectomy, a common and well-validated surgical model often used to study postsurgical pain for foot and ankle procedures. Prior to the surgical procedure, patients received 133 mg (10 mL) of EXPAREL mixed with 20 mL saline OR 50 mg (20 mL) of 0.25% bupivacaine HCl mixed with 10 mL saline via sciatic nerve block in the popliteal fossa. All patients received 100 mg (20 mL) of 0.5% immediate-release bupivacaine HCl as a Mayo field block after study drug administration

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

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

Learn more about lower extremity nerve blocks with EXPAREL

Check out the news, data, and clinical resources which support the use of EXPAREL in lower extremity procedures

The latest

FDA Approval Press Release

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Clinical Studies

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Clinical resources

Sciatic Nerve Block in the Popliteal Fossa Study

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EXPAREL vs bupivacaine HCI

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Sciatic Nerve Block in the Popliteal Fossa

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EXPAREL can be used to achieve sensory block in several areas

Visualize regional pain control techniques and blocks by surgical sites, explore techniques used in real-world cases, and discover how EXPAREL may support your patients' recovery after surgery with the EXPAREL InSite tool

Check out InSite

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.

Reference

  1. Schwartz G, Gadsden JC, Gonzales J, et al. A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy. J Clin Anesth. 2024;94:111402.
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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