Exparel vs Block for ACL Reconstruction

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT06006624
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • ACL
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Exparel 30 mL — DRUG
    30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
  • 0.5% bupivacaine — DRUG
    5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
  • Dexamethasone — DRUG
    10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal
  • iPACK block — DRUG
    iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block

Study Details

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.

Key Dates

Start date
Aug 21, 2023
Status verified
Jun 2024
Primary completion
Oct 30, 2024
Completion
Oct 30, 2024

Study Design

Enrollment
154 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)
  • 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)

Primary Outcome Measure

Postoperative Pain [ Time Frame: 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

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