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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2025 to Dec 1, 2025
    • Site details revised
    v7
  2. Study description expanded, about 1 wordv6
  3. Start date: Jun 2025 to Sep 2025v5 Show 5 more changesShow less
    • Primary completion date: Jun 2027 to Sep 2027
    • Study completion date: Jun 2028 to Sep 2028
    • Study description expanded, about 24 words
    • Site contact updated
    • Eligibility criteria expanded, about 3 words
  4. Start date: Dec 2024 to Jun 2025
    • Primary completion date: Dec 2026 to Jun 2027
    • Study completion date: Dec 2026 to Jun 2028
    • Site contact updated
    v4
  5. Start date: Sep 2024 to Dec 2024
    • Eligibility criteria expanded, about 26 words
    • Study description expanded, about 93 words
    • Site contact updated
    v3
  6. Primary endpoints revised (4)
    • Secondary endpoint revised
    • Study description expanded, about 11 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06559215
Lead Sponsor Texas Scottish Rite Hospital for Children
Conditions
(from sponsor)		 Medial Patellofemoral Ligament (MPFL) Reconstruction, Sports Injuries in Children, Analgesia, Pain, Postoperative
Related terms Agnosia, Postoperative Pain
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov