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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 21
Healthy Volunteers: f
View:

• Must be aged 13+ years at time of surgery

• Must present with injury requiring an isolated MPFL Reconstruction

• Ability to provide assent, legally appointed representative available to provide informed consent

Locations
United States
Texas
Texas Scottish Rite Hospital for Children
RECRUITING
Frisco
Contact Information
Primary
Robert Van Pelt, MPH
bobby.vanpelt@tsrh.org
2145597456
Backup
Anna Wilhelmy, MS
anna.wilhelmy@tsrh.org
469-857-2109
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2028-09
Participants
Target number of participants: 100
Treatments
Active_comparator: Exparel + Marcaine Group
Local Infiltration: Regardless of weight: 10 mL Exparel and 10 mL 0.25% Marcaine
No_intervention: Marcaine Only Group
Local Infiltration: Regardless of weight: 20 mL 0.25% Marcaine
Related Therapeutic Areas
Sponsors
Leads: Texas Scottish Rite Hospital for Children

This content was sourced from clinicaltrials.gov