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Exparel vs Block for ACL Reconstruction

NCT06006624 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-06-21

No results posted yet for this 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.

Conditions

  • ACL
  • Postoperative Pain

Interventions

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

Dexamethasone

10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal

DRUG

iPACK block

iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2024-10-30
Completion
2024-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06006624 on ClinicalTrials.gov