Clinical Trial

Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population

Recruiting Phase 2
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Summary
The goal of this randomized clinical trial is to determine if administration of Exparel via local infiltration for medial patellofemoral ligament (MPFL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are: * Does Exparel significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does Exparel significantly decrease narcotic use (number of pills taken) up to one week postoperatively? Researchers will compare the pain outcomes and narcotic use of patients who receive Exparel and Marcaine via local infiltration to those of patients who receive only Marcaine via local infiltration for their MPFL reconstruction surgery. The goal is to understand if there is a significant difference in patient pain outcomes and narcotic use outside the first 24 hours postoperatively. Participants will: * receive either Exparel + Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery * receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction * receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery at postoperative day 1
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-08-15; most recent amendment 2026-03-05.
Status change: Not Yet Recruiting → Recruiting 2026-03-05
Trial Details
NCT Number NCT06559215
Lead Sponsor Texas Scottish Rite Hospital for Children
Conditions Medial Patellofemoral Ligament (MPFL) Reconstruction, Sports Injuries in Children, Analgesia, Pain, Postoperative
Enrollment 100 participants
Start Date 2025-12-01
Primary Completion 2027-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-09