Exparel vs Block for ACL Reconstruction

Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial

Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Pain; ACL
• Intervention / Treatment: Drug: Exparel 30 mL; Drug: 0.5% bupivacaine; Drug: iPACK block; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons
• Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis
• Age 18 and older
• English speaking
• Ability to complete surveys by phone or in person
• Ability to provide informed consent

Exclusion Criteria:

• Revision cases
• Multi-ligamentous knee injuries
• Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol
• ACL reconstruction utilizing non-bone-patellar tendon-bone autografts
• Allergies to study medications
• Non-English speakers
• Known alcohol or narcotic abuse history
• Existing contract with a pain specialist due to underlying preoperative pain syndrome
• Preoperative opioid use within the 3 months prior to surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: ACL repair + Exparel + nerve block; 30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total)	Drug: Exparel 30 mL; 30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block; Drug: 0.5% bupivacaine; 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal; Drug: iPACK block; iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block
Active Comparator: Group 2: ACL repair + Exparel + Dexamethasone + nerve block; 30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total)	Drug: Exparel 30 mL; 30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block; Drug: 0.5% bupivacaine; 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal; Drug: iPACK block; iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block; Drug: Dexamethasone; 10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain	14 days
Postoperative opioid use	assessed using a participant daily diary of how much medication was taken daily for pain	14 days
Postoperative Pain #2	Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain	14 days

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: SHAM2023-2163

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No