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Recruiting Phase 2 NCT06559215

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

Trial Parameters

Condition Medial Patellofemoral Ligament (MPFL) Reconstruction
Sponsor Texas Scottish Rite Hospital for Children
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 100
Sex ALL
Min Age 13 Years
Max Age 21 Years
Start Date 2025-12-01
Completion 2027-09
Interventions
Exparel

Brief 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 Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Patient \<13 years old * Requires fracture repair or another non-standardized surgery * Any MPFL Reconstruction that requires the use of arthrotomy or a tibial tubercle osteotomy * Any lower extremity procedure that is not an isolated MPFL Reconstruction * Patient pregnancy * Inability to provide assent or legally appointed representative to provide informed consent * Prior history of hypersensitivity to Exparel or any local anesthesia * BMI ≥ 40

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