About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ASA I, II and III
10-18 years of age
scheduled for ACL reconstruction
agreeable to regional block and follow-ups
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidance
DrugThe local anesthetic (ropivacaine) + dexmedetomidine will be administered via single-shot adductor canal block under ultrasound guidance
Treatment groups
Trial outcomes
Primary outcomes
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,
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%.
Secondary outcomes
Pain control
Patient will report pain on an 11-item numerical rating scale, where 0 = no pain and 10 = worst pain imaginable
Duration of post-anesthetic care unit stay
Duration of stay in post-anesthetic care unit, in minutes
Total opioid consumption
Milligrams of opioid per day, quantified as morphine equivalents. Data collected from electronic medical record and on patient visit at postoperative day 14 to clarify amount taken post-discharge.
Patient Satisfaction
Patient asked to rate satisfaction regarding pain management on a 5-item scale, ranging from Very dissatisfied to Very satisfied
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