Phase 4 N=32 Randomized Triple-blind Treatment

Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Rupture

Bottom Line

View on ClinicalTrials.gov: NCT02189317 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Change in Numerical Rating Scale (NRS) Pain Score — 3.6; 4.7; 5.0; 4.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Exparel (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Numerical Rating Scale (NRS) Pain Score	3.6; 4.7; 5.0; 4.1; 5.7; 4.5	—
SECONDARY Change in Home Opioid Use	10.2; 9.3; 1.6; 2.5; 4.9; 4.1	—
SECONDARY Difference in Time to First Opioid Use	3.2; 3.1	—

Summary

This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into treatment and control arms. The treatment arm will include 40 patients receiving liposomal bupivacaine intra-operatively in addition to the current standard pain control regimen. The control group will include 40 patients receiving the standard post-operative pain control regimen. Patients will be assessed to identify differences in post-operative pain, satisfaction, as well as concomitant pain medication use. Post-operative range of motion will also be assessed.

Eligibility Criteria

Inclusion Criteria

Ages between 18 and 50 chronological years undergoing ACL reconstruction using a quadriceps tendon or BTB autograft.

Exclusion Criteria

Patients with known allergies to local anesthetics
pregnant patients
patients with a history of liver disease
patients undergoing bilateral procedures
Patients undergoing revision ACL surgery and patients undergoing ACL reconstruction using pediatric physeal sparing techniques
Patients will also be excluded if any clinically significant event or condition is discovered during the time of, or after surgery that may render them medically unstable, or subject them to a surgical complication.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02189317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.