Recruiting
Phase 3

ACB

Sponsor:

Isabella Jaramillo

Code:

NCT06875427

Conditions

Anterior Cruciate Ligament

Anterior Cruciate Ligament (ACL) Tear

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06875427

Start date

Jul 1, 2025

Status verified date

Sep, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients ASA I, II and III
  • 10-18 years of age
  • scheduled for ACL reconstruction
  • agreeable to regional block and follow-ups

Exclusion Criteria:

  • 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

Study Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single-shot adductor canal block

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.

no intervention: Non-block

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

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

Primary outcome measure

  • Change in Quality of Recovery scores [ Time Frame: 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 [ Time Frame: Period of recruitment is expected to be 12 months ]

Central Contacts and Locations

Central contacts

Locations

McMaster Children's Hospital, Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

More Information

Sponsor

Isabella Jaramillo

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • single-shot adductor canal block
  • anterior cruciate ligament reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Isabella Jaramillo on 2025-09-26.