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Regional Blocks for Lateral Condyle Fractures

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv10
  2. Minor Site contact updatedv9
  3. Notable Primary completion date: Jan 7, 2025 to Jan 7, 2027
    • Study completion date: Mar 7, 2025 to Mar 7, 2027
    v8
  4. Notable Primary completion date: Jan 7, 2024 to Jan 7, 2025
    • Study completion date: Mar 7, 2024 to Mar 7, 2025
    v7
  5. Minor Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Primary completion date: Jan 7, 2021 to Jan 7, 2024
    • Study completion date: Mar 7, 2021 to Mar 7, 2024
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2019 to Jan 7, 2021
    • Start date changed from estimate of May 27, 2019 to Sep 16, 2019
    • Study sites: 0 to 1
    • Study completion date: Mar 30, 2020 to Mar 7, 2021
  3. Notable Start date: Jan 1, 2019 to May 27, 2019v3
  4. Minor Secondary endpoints: details revised at 1 of 1 entry
    • Study description revised
    • Eligibility criteria shortened, about 2 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to investigate the post-operative pain control in pediatric patients with closed lateral condyle fractures who undergo open reduction and percutaneous pinning. Patients will be randomized into one of two groups. Group 1 will receive an infraclavicular nerve block to the affected extremity by a fellowship trained pediatric anesthesiologist prior to surgery. Group 2 will undergo the Orthopaedic Institute of Children's (OIC) standard preoperative protocol. Post-operative pain management will be the same for both groups per standard protocol. Pain level will be assessed post-operatively using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. All patients in both groups will receive standard oxycodone solution prescriptions post-operatively as per typical protocol. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery and 1st post-op visit). This study is being conducted in hopes of developing comprehensive pain management protocols to reduce opioid consumption after surgical fixations of displaced lateral condyle fractures if the study can show that patients are more satisfied and require less opioid medication when receiving preoperative regional anesthesia.
Trial Details
NCT Number NCT03796572
Lead Sponsor University of California, Los Angeles
Conditions
(from sponsor)
Fractures, Closed, Humeral Fractures, Pain
Related terms Fractures, Closed, Humeral Fractures, Pain
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov