Inpatient

EXPAREL vs bupivacaine in inpatient TKA1

Study Objective: To compare postoperative pain scores and functional outcomes between EXPAREL and an ACB using bupivacaine HCl in patients undergoing primary TKA

Investigator-initiated

Key outcomes of interest were

icon postoperative pain
Postoperative pain measured using a VAS
icon cost differences
Cost differences between the 2 medications

Results

EXPAREL was noninferior to bupivacaine ACB in additional study outcomes

With EXPAREL, on average:

  • Differences in VAS scores were small at each time point, ranging from 0.03 to 0.9
  • VAS scores were significantly higher on POD 2 than on POD 0 in both groups

EXPAREL use resulted in lower costs for the institution

EXPAREL delivered similar clinical outcomes to bupivacaine ACB at a lower cost.

EXPAREL was noninferior to bupivacaine ACB in:

  • VAS scores on PODs 0, 1, 2, 4, and 7
  • WOMAC scores
  • Knee flexion
  • Knee extension
  • Ambulation distance
  • Morphine milligram equivalents
  • Hospital LOS

WOMAC scores increased from the preoperative period by 23.8 and 33 points at 3-4 and 7-8 weeks postoperation, respectively

icon knee flexion
Knee flexion decreased

Knee flexion decreased by 10.8 points at 3-4 weeks postoperation from the preoperative period

icon knee extensions
Knee extension increased

Knee extension increased by 1.1 points at 3-4 weeks postoperation from the preoperative period

Overall costs for EXPAREL were lower vs bupivacaine ACB due to the higher total price of ACB, which included the anesthesiologist procedure fee, the medication, and the materials. A statistical analysis was not performed.

Non–cost-related outcomes were not statistically significant across both groups.

diagram cost to institution per patient
  • This was a randomized controlled trial of 57 patients with 60 TKA procedures performed by a single orthopedic surgeon at a community-based teaching hospital between March 2017 and March 2018
  • Patients were required to be over 18 years old and undergoing a unilateral primary TKA for end-stage osteoarthritis or rheumatoid arthritis
  • Patients were randomized to receive EXPAREL intraoperatively or a preoperative ACB using bupivacaine HCl
  • Both groups also received the institutional standard multimodal pain protocol, which included preemptive oral pain medications, a spinal anesthetic, and a standard intraoperative peri-articular injection (PAI) with bupivacaine HCl, ketorolac, and morphine
  • Baseline characteristics were well balanced between groups (P>0.05)
  • The sample size was relatively small and may have been underpowered to detect clinically significant differences in the secondary outcomes
  • The providers and the patients were not blinded in the study, potentially adding bias to the outcome scores
  • Study results are not generalizable to opiate-dependent patients because they were excluded from the study
  • No statistical analyses were performed for costs

ACB, adductor canal block; HCl, hydrochloride; LOS, length of stay; POD, postoperative day; TKA, total knee arthroplasty; VAS, visual analog scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

Reference: 1. Than J, et al. Arthroplast Today. 2021;9:21-28. doi:10.1016/j.artd.2021.03.008

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Important Safety Information

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.

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
Important Safety Information
Important Safety Information

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.