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Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Eligibility criteria expanded, about 9 words Show 4 more changesShow less
    • Secondary endpoints: details revised at 6 of 12 entries
    • Study description expanded, about 8 words
    • Site contact updated
    • Publications: details revised at 12 of 12 entries
  2. Primary completion date: Oct 2026 to Jun 2027
    • Study completion date: Oct 2028 to Jan 2028
    • Start date changed from estimate of Apr 2025 to Jun 6, 2025
    v8
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2025 to Apr 2025
    • Study sites: 0 to 1
    v7
  4. Start date: Jan 2025 to Feb 2025v6
  5. Eligibility criteria revised
    • Secondary endpoints: 10 to 12
    • Study description expanded, about 37 words
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Oct 2024 to Jan 2025v4
  2. Secondary endpoints: details revised at 2 of 10 entriesv3
  3. Start date: Sep 1, 2024 to Oct 2024
    • Primary completion date: Sep 1, 2026 to Oct 2026
    • Study completion date: Sep 1, 2028 to Oct 2028
    • Secondary endpoints: details revised at 4 of 10 entries
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pilot clinical trial is to compare anterior femoral cutaneous nerve block (AFCN) to adductor canal block ACB) for pediatric patients undergoing either anterior cruciate ligament (ACL) or medial patellofemoral ligament (MPFL). The aims of this trial are: * To measure postoperative functional outcomes in patients who received AFCNB vs. ACB. * To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs. ACB. * To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs. ACB. * To quantify sensory deficits in patients who received AFCNB vs. ACB. * To assess patient-reported outcome measures (e.g., pain expectation scale, pain management satisfaction, PROMIS Pediatric Short Form v1.0 - Physical Activity, PROMIS Scale v1.2 - Global Health) in patients 8-18 years of age who received AFCNB vs. ACB. Subjects undergoing ACL procedures will be compared between those who received the adductor canal block to those who received the anterior femoral cutaneous nerve block. The researchers will also compare individuals who underwent MPFL procedures and received an anterior femoral cutaneous nerve block with those who received the adductor canal block. Participants will: * Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia. * Maintain a patient diary to document daily pain meds/pain scores * Complete follow up surveys/questionnaires via telephone and during their office visits with surgeons.
Trial Details
NCT Number NCT06590402
Lead Sponsor Hospital for Special Surgery, New York
Conditions
(from sponsor)		 Anterior Cruciate Ligament Reconstruction, Medial Patellofemoral Ligament Reconstruction
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov