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

RecruitingPhase 2Ages 13 Years - 21 YearsAllTexas Scottish Rite Hospital for Children
NCT06559215 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Exparel
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Where

1 site
Texas Scottish Rite Hospital for Children
Frisco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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