RecruitingPhase 3NCT06875427

ACB vs no Block for Pediatric ACL Reconstruction

Comparing Preoperative Adductor Canal vs. No Block for Quality of Recovery After Anterior Cruciate Ligament Reconstruction in Patients Younger Than 18 Years of Age: A Randomized Controlled Feasibility Trial


Sponsor

Isabella Jaramillo

Enrollment

38 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized controlled feasibility clinical trial is to assess the feasibility of conducting a randomized trial of adding a perioperative single-shot adductor canal block to standard of care general anesthesia compared to non-regional techniques in pediatric patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction. The main clinical question it aims to answer is does ACB result in improved Quality of Recovery-15 questionnaire scores on postoperative day 2 , postoperative day 14, and postoperative day 42. Secondary questions this study will address are will use of a single-shot adductor canal block result in: less total opioid consumption; shorter post anesthetic care unit (PACU) length of stay; better pain scores at rest and with movement at time of postoperative phone call; and patient satisfaction score at 2 weeks (postoperative day 14). Researchers will compare the scores to patients undergoing the same surgery who will not have a single-shot ACB. All patients will receive the same pre-, peri-, and postoperative care with the exception of being randomized to block or no block. Participants will be asked to answer the Quality of Recovery-15 questionnaire and rate their pain on a scale of 0-10 on the day of surgery, at postoperative day 2 (by telephone) and at postoperative day 14 and postoperative day 42 during regular orthopedic clinic follow-up. Patients and caregivers will rate their satisfaction at postoperative day 42, using a 5-item Likert scale (ranging from completely dissatisfied to completely satisfied).


Eligibility

Min Age: 10 YearsMax Age: 18 Years

Inclusion Criteria4

  • Patients ASA I, II and III
  • -18 years of age
  • scheduled for ACL reconstruction
  • agreeable to regional block and follow-ups

Exclusion Criteria6

  • Contraindications to adductor canal block.
  • Patients with coagulopathies, preexisting neurologic deficit
  • Significant comorbidities that may impact recovery or interfere with the study.
  • Refusal to regional techniques.
  • Moderate to severe cognitive deficit (patients who are unable to complete the questionnaire)
  • Patients with history of malignant hyperthermia

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Interventions

DRUGRopivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidance

The local anesthetic (ropivacaine) + dexmedetomidine will be administered via single-shot adductor canal block under ultrasound guidance


Locations(1)

McMaster Children's Hospital, Hamilton Health Sciences

Hamilton, Ontario, Canada

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NCT06875427


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