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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.

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 hip surgery

THA

Study design1

Retrospective study comparing the efficacy of standard THA pain management with adjunct EXPAREL (n=586) versus standard THA pain management alone (n=686) in patients undergoing THA.

Multimodal protocol

PREOPERATIVE

INTRAOPERATIVE

POSTSURGICAL

PREOPERATIVE

  • Celecoxib 200 mg orally
  • Acetaminophen 1000 mg orally
  • Pregabalin 50 mg orally

INTRAOPERATIVE

  • Both groups:
    • Spinal (preferred) or general (alternate) anesthesia
    • Injection of bupivacaine HCl + epinephrine 0.25% 40 mL,* morphine sulfate (1 mg/mL) 5 mL, and ketorolac (30 mg/mL) 1 mL
  • THA + EXPAREL group:
    • Periarticular injection of EXPAREL 266 mg/20 mL in 0.9% saline 40 mL
  • THA group:
    • No EXPAREL administered

POSTSURGICAL

  • Patient-controlled analgesia for up to 24 hours after surgery
  • Oral opioid as needed
  • Morphine/hydromorphone HCI intravenously as needed for breakthrough pain

Patients who received multimodal analgesia with EXPAREL

Significant pain reduction
  • 8 hours after surgery (P=0.031)
Fewer opioids used†‡
  • POD 1 (P=0.001)
  • POD 2 (P=0.016)
Achieved more physical therapy milestones
  • Gait: 82% vs 64% (P<0.001)
  • Stairs: 93% vs 76% (P<0.001)

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

†Opioid intake measured in MED (mg).

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

MED, morphine equivalent dosing; THA, total hip arthroplasty;

Study design2

Retrospective chart review that analyzed the outcome and feasibility of same-day discharge using an ERAS protocol in the inpatient setting in Medicare patients undergoing TKA (n=337) or THA (n=308).

Multimodal protocol

  • Patients were required to have a friend or family member who could assist with nonsurgical care and provide support on the day of surgery and for 3 days after surgery, in order to maintain adherence with medication, exercise, and analgesia protocols
  • Patients and their assistants were educated on realistic pain expectations, dangers related to opioid use, opioid tapering, sleep hygiene, exercise and walking programs, walker safety, wound care, and home preparation
  • 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/20 mL, bupivacaine HCl, and adjuncts
  • THA-specific protocol
  • Anterior lateral femoral cutaneous nerve field block with EXPAREL 266 mg/20 mL and bupivacaine HCl
  • TKA-specific protocol
  • Adductor canal block with bupivacaine HCl
  • Restricted intravenous opioid during surgery

Patients who received multimodal analgesia with EXPAREL

Same-day discharge
  • 84% of patients were discharged on the day of surgery
High pain management satisfaction
  • 98.3% of patients were “very much” or a “good amount” satisfied with their pain management
Postsurgical opioid use*
  • 84.2% of patients did not require an opioid prescription beyond the initial 7-day prescription provided at discharge

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

ERAS, enhanced recovery after surgery; THA, total hip arthroplasty; TKA, total knee arthroplasty.

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. Yu SW, Szulc AL, Walton SL, Davidovitch RI, Bosco JA, Iorio R. Liposomal bupivacaine as an adjunct to postoperative pain control in total hip arthroplasty. J Arthroplasty. 2016;31(7):1510-1515.
  2. Van Horne A, Van Horne J. Patient-optimizing enhanced recovery pathways for total knee and hip arthroplasty in Medicare patients: implication for transition to ambulatory surgery centers. Arthroplast Today. 2019;5(4):497-502.
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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