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

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable 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 28 words
    • Site contact updated
    • Eligibility criteria expanded, about 3 words
  2. Notable 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
  3. Notable Start date: Sep 2024 to Dec 2024
    • Eligibility criteria expanded, about 29 words
    • Study description expanded, about 91 words
    • Site contact updated
    v3
  4. Notable Primary endpoints revised (4)
    • Secondary endpoint revised
    • Study description expanded, about 12 words
    v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 single-shot ropivacaine peripheral nerve blocks (PNB - perineural injections) for anterior cruciate ligament (ACL) 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 ropivacaine significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does ropivacaine significantly decrease narcotic use (number of pills taken) up to one week postoperatively? Researchers will compare the pain outcomes and narcotic use of participants who receive a single-shot ropivacaine peripheral nerve block to those of participants who do not receive a single-shot ropivacaine peripheral nerve block for their ACL reconstruction surgery. The goal is to understand if there is a significant difference in participant pain outcomes and narcotic use outside the first 24 hours postoperatively. Participants will: * receive either a single-shot ropivacaine peripheral nerve block intraoperatively or no peripheral nerve block during their ACL Quadriceps tendon graft or bone patellar tendon bone graft 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 ACL reconstruction surgery at postoperative day 1
Trial Details
NCT Number NCT06559137
Lead Sponsor Texas Scottish Rite Hospital for Children
Conditions
(from sponsor)
Anterior Cruciate Ligament (ACL) Tear, Sports Injuries in Children, Analgesia, Pain, Postoperative
Related terms Agnosia, Lacerations, Postoperative Pain
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov