Actively Recruiting

Phase 2
Age: 13Years - 21Years
All Genders
NCT06559215

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

Led by Texas Scottish Rite Hospital for Children · Updated on 2026-03-09

100

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 13Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be aged 13 years or older at time of surgery
  • Must have an injury requiring an isolated MPFL reconstruction
  • Ability to provide assent or have a legally appointed representative to give informed consent
Not Eligible

You will not qualify if you...

  • Younger than 13 years old
  • Requires fracture repair or another non-standardized surgery
  • MPFL reconstruction involving arthrotomy or tibial tubercle osteotomy
  • Any lower extremity surgery other than isolated MPFL reconstruction
  • Pregnancy
  • Unable to provide assent or have a legally appointed representative to give informed consent
  • Prior hypersensitivity to Exparel or any local anesthesia
  • Body mass index (BMI) of 40 or higher

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Trial Site Locations

Total: 1 location

1

Texas Scottish Rite Hospital for Children

Frisco, Texas, United States, 75034

Actively Recruiting

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Research Team

R

Robert Van Pelt, MPH

CONTACT

A

Anna Wilhelmy, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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