Actively Recruiting

Phase 3
Age: 10Years - 18Years
All Genders
ID06875427

Comparing Preoperative Adductor Canal Block Versus No Block for Recovery Quality After ACL Reconstruction in Patients Under 18: A Randomized Feasibility Trial

Led by Isabella Jaramillo · Updated on 2025-09-26

38

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Isabella Jaramillo

Lead Sponsor

M

McMaster University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility of a randomized trial comparing perioperative single-shot adductor canal block (ACB) with standard general anesthesia without regional block in children and adolescents aged 10 to 18 undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction. The study aims to determine if ACB improves quality of recovery as measured by the Quality of Recovery-15 questionnaire at several postoperative time points. Secondary questions include whether ACB reduces opioid use, shortens post-anesthetic care unit stay, improves pain scores, and increases patient satisfaction. Participants will be randomly assigned to receive either a single-shot ACB with ropivacaine and dexmedetomidine after induction of general anesthesia or no nerve block, with all other care standardized between groups. The nerve block is performed under ultrasound guidance. Patients in the non-block group will have a dressing placed to maintain blinding. Follow-up visits occur at postoperative days 2, 14, and 42. During the study, participants and caregivers will complete the Quality of Recovery-15 questionnaire and pain rating scales on the day of surgery and at follow-up calls or clinic visits. Satisfaction ratings will be collected at postoperative day 42 using a 5-item scale. Researchers will also monitor opioid consumption, post-anesthetic care unit time, and any hospital admissions until day 42. Enrollment feasibility will be assessed based on recruitment rates over a 12-month period.

CONDITIONS

Brief Title

ACB vs no Block for Pediatric ACL Reconstruction

Who Can Participate

Age: 10Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients classified as ASA I, II, or III
  • Aged between 10 and 18 years
  • Scheduled to undergo anterior cruciate ligament reconstruction
  • Agreeable to receive regional nerve block and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Contraindications to adductor canal block
  • Presence of bleeding disorders or coagulopathies
  • Preexisting neurological deficits
  • Significant other medical conditions affecting recovery or study participation
  • Refusal of regional anesthesia techniques
  • Moderate to severe cognitive impairment preventing questionnaire completion
  • History of malignant hyperthermia

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants undergo anterior cruciate ligament reconstruction surgery with either a preoperative single-shot adductor canal block or no nerve block as part of their pain management.

1 surgical visit

Post-operative Follow-up

Duration - 42 days after surgery

Participants are observed and assessed for recovery quality, pain control, opioid consumption, and satisfaction after surgery.

Follow-up assessments on postoperative days 2, 14, and 42

Trial Site Locations

Total: 1 location

1

McMaster Children's Hospital, Hamilton Health Sciences

Hamilton, Ontario, Canada, L8N 3Z5

Actively Recruiting

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Research Team

I

Isabella Jaramillo, MD

T

Toni Tidy, BSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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