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RECRUITING
NCT06559215
PHASE2

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

Sponsor: Texas Scottish Rite Hospital for Children

View on ClinicalTrials.gov

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

Official title: Prospective Evaluation of Post-operative Pain Management Using Exparel in the Pediatric Population

Key Details

Gender

All

Age Range

13 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-12-01

Completion Date

2028-09

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Exparel

Patients will be randomized to receive Exparel intraoperatively via local infiltration.

Locations (1)

Texas Scottish Rite Hospital for Children

Frisco, Texas, United States