Recruiting PHASE3 Anterior Cruciate Ligament

Compares treatment options for Anterior Cruciate Ligament

Official title ACB vs no Block for Pediatric ACL Reconstruction

ClinicalTrials.gov ID: NCT06875427

What this study is testing

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

Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidance is an investigational medicine, being studied as a potential treatment for anterior cruciate ligament.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 10 to 18

You may be able to join if

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

You likely can't join 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

The study team makes the final eligibility decision.

Where it's taking place

  • Hamilton, Ontario, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 10 years to 18 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.