ACB vs no Block for Pediatric ACL Reconstruction

NCT06875427 | Recruiting Phase 3

• 1 other identifier: ssACB2024
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anterior Cruciate Ligament; Anterior Cruciate Ligament (ACL) Tear

Keywords

single-shot adductor canal block; anterior cruciate ligament reconstruction

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Recovery scores

  Assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a validated 15-item questionnaire (patient survey). This questionnaire has 15 questions, each of which is answered on an 11-point Likert scale, where 10 = none of the time and 0 = All of the time. Final scores can range from 0 to 150. Scores will be compared between arms to see whether there is a difference in quality of recovery,

  From day of surgery until end of study (postoperative day 42), collected at 4 timepoints: Day of surgery, postoperative day 2, postoperative day 14, postoperative day 42

• Enrollment rate

  To determine feasibility, as defined as the proportion of participants enrolled over the number of participants approached. The investigators will declare feasibility if the enrollment rate is ≥ 80%.

  Period of recruitment is expected to be 12 months

Secondary Outcomes (6)

• Pain control

  From day of surgery until end of study (postoperative day 42), collected on postoperative day 0, postoperative day 2, postoperative day14 and postoperative day 42

• Duration of post-anesthetic care unit stay

  From time of time of hand-off to post-anesthetic care unit staff to discharge from the post-anesthetic care unit (usually by 2 hours [120 minutes])

• Total opioid consumption

  Day of surgery to postoperative day 14. Includes opioids used intraoperatively, in post-anesthetic care unit, and post-discharge.

• Patient Satisfaction

  From day of surgery to postoperative day 42. Patient is asked to rate satisfaction on day of surgery and again on postoperative day 42

• Caregiver Satisfaction

  From day of surgery to postoperative day 42. Caregiver is asked to rate satisfaction on day of surgery and again on postoperative day 42

Study Arms (2)

Single-shot adductor canal block

EXPERIMENTAL

All the patients will receive a standardized general anesthetic technique, and adductor canal nerve block will be performed after induction using ropivacaine 2-2.5 mg/kg + dexmedetomidine 1 mcg/kg. IV placement in case of inhalational induction and airway secured.

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

Non-block

NO INTERVENTION

A general anesthetic will be performed as for the block group. NO nerve block will be performed. Dressing will be placed in the intended area of a block to maintain patient blinding.

Interventions

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

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

Single-shot adductor canal block

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isabella Jaramillo: lead
• McMaster University: collaborator

Study Sites (1)

McMaster Children's Hospital, Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

MeSH Terms

Conditions

Lacerations

Interventions

Ropivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Isabella Jaramillo, MD

CONTACT

905-379-9241; jaramilc@mcmaster.ca

Toni Tidy, BSc

CONTACT

1-905-525-9140; tonitidy@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Research assistants involved in patient recruitment and follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized controlled feasibility study

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: March 13, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The investigators plan to publish the protocol in a peer-reviewed journal
• Access Criteria: The IPD may be requested from the PI.

Locations

CA (1)