Outpatient, single-center, parallel, unblinded, randomized clinical trial

Randomized clinical trial comparing mixed liposomal bupivacaine vs continuous catheter for interscalene block during shoulder arthroplasty: a comparison of analgesia, patient experience, and cost1

Study Objective: To examine the analgesic efficacy, quality of recovery, and treatment costs of an interscalene brachial plexus nerve block using single-shot EXPAREL or continuous catheter using bupivacaine HCl in patients undergoing TSA.

This was a single-center, parallel, unblinded, randomized clinical trial in adult patients conducted at a high-volume academic orthopedic center between December 2021 and March 2023. A total of 83 patients undergoing primary unilateral shoulder arthroplasty were randomized and analyzed: 44 in the continuous interscalene block group and 39 in the mixed liposomal bupivacaine single-injection group. The continuous catheter group received a preoperative 15–20 mL bolus of 0.5% bupivacaine HCl premixed with epinephrine (5 mcg/mL), followed by a postoperative continuous infusion of 0.2% bupivacaine HCl at 8 mL/h for 69 hours. The single-injection group received an admixture of 10 mL (133 mg) EXPAREL and 5 mL of 0.5% bupivacaine HCl. Costs were evaluated through postoperative day 3 using a detailed, process-mapped, time-driven, activity-based costing analysis to directly allocate expenses for labor, equipment, supplies, and medications.

Limitations:
The target population was limited strictly to primary shoulder arthroplasty, which limits how well these findings generalize to other procedures like shoulder arthroscopy or revision arthroplasty. Patients and healthcare providers were not blinded to the treatment groups, potentially introducing bias. The study did not include a third comparison arm evaluating a single injection of bupivacaine HCl, which would have required a much larger sample size to execute.

Key outcomes of interest:

icon post surgery
Pain at rest 24 hours postsurgery
icon pain
Pain scores*
icon opiod
Opioid consumption*
icon complications
Complications*
icon quality recovery
Quality of recovery*
icon time driven
A time-driven, activity-based cost analysis*

*Collected through POD 3 using a combination of telephone follow-up and routine clinical documentation by nursing, anesthesia, and surgical care teams.

Results

EXPAREL was associated with 28% cost savings after outpatient TSA

There was no statistically significant difference in median NRS pain scores at rest at 24 hours postsurgery between the continuous interscalene catheter group and the single-injection mixed EXPAREL group (1.0 vs 1.0; p=0.433).

Comparable analgesia, daily opioid consumption, and quality of recovery (QoR-15) scores were observed between both groups through POD 3.

In terms of cost, the mixed EXPAREL interscalene block was associated with a 28% reduction in overall treatment costs compared to the continuous catheter approach ($448.84 vs $624.29).

Limitation: The trial was powered specifically to detect differences in the primary outcome (pain at 24 hours), meaning secondary outcomes were not adjusted for multiple comparisons and should be considered preliminary.

diagram overall treatment cost

HCl, hydrochloride; NRS, Numeric Rating Scale; POD, postoperative day; TSA, total shoulder arthroplasty.

Reference: 1. Panchamia JK, et al. J Shoulder Elbow Surg. 2025;34:2178-2189. doi:10.1016/j.jse.2024.09.051

This page will be updated with further studies as they become available

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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.