Exparel vs Block for ACL Reconstruction

Last updated: June 19, 2024
Sponsor: Rothman Institute Orthopaedics
Overall Status: Active - Enrolling

Phase

4

Condition

Chronic Pain

Acute Pain

Pain

Treatment

iPACK block

Dexamethasone

Exparel 30 mL

Clinical Study ID

NCT06006624
SHAM2023-2163
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Paticipants with ACL rupture amenable to reconstruction with BTB autograftidentified in clinic by one of 4 different surgeons

  • Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateralextra-articular tenodesis

  • Age 18 and older

  • English speaking

  • Ability to complete surveys by phone or in person

  • Ability to provide informed consent

Exclusion

Exclusion Criteria:

  • Revision cases

  • Multi-ligamentous knee injuries

  • Cartilage or meniscal procedures that prevent adherence to immediate weight bearingand 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 painsyndrome

  • Preoperative opioid use within the 3 months prior to surgery

Study Design

Total Participants: 154
Treatment Group(s): 4
Primary Treatment: iPACK block
Phase: 4
Study Start date:
August 21, 2023
Estimated Completion Date:
October 30, 2024

Connect with a study center

  • Rothman Orthopaedic Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

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