MedTrace Logo

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

NCT06559215 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-09

No results posted yet for this study

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

Conditions

  • Analgesia
  • Medial Patellofemoral Ligament (MPFL) Reconstruction
  • Sports Injuries in Children
  • Pain, Postoperative

Interventions

DRUG

Exparel

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

Sponsors & Collaborators

  • Texas Scottish Rite Hospital for Children

    lead OTHER

Principal Investigators

  • Philip Wilson, MD · Texas Scottish Rite Hospital for Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-09-30
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06559215 on ClinicalTrials.gov