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RECRUITING
NCT06875427
PHASE3

ACB vs no Block for Pediatric ACL Reconstruction

Sponsor: Isabella Jaramillo

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2025-07-01

Completion Date

2027-01

Last Updated

2025-09-26

Healthy Volunteers

No

Interventions

DRUG

Ropivacaine 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