A Phase 3 interventional study of Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidance in Anterior Cruciate Ligament and Anterior Cruciate Ligament (ACL) Tear, sponsored by Isabella Jaramillo. Recruiting at 1 site in Canada. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Isabella Jaramillo · Phase 3, Interventional, and Treatment
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).
Anterior cruciate ligament (ACL) injuries are becoming increasingly common among children and adolescents as they are engaging in contact sports at younger ages, which may contribute to a higher incidence of musculoskeletal injuries. This heightened susceptibility could be attributed to increased joint flexibility and potential immaturity in musculoskeletal development, with ACL reconstruction (ACLR) being the primary treatment approach. Effective pain management in the early postoperative phase is crucial, as it significantly impacts the ability to start rehabilitation and return to sports activities. Despite approximately 200,000 adolescents undergoing ACLR annually, there are no established benchmarks for pain management in this population, and significant variability exists in pain management practices in pediatric ACL reconstruction. Regional nerve blocks, such as femoral nerve blocks (FNBs), adductor canal blocks (ACBs), and sciatic nerve blocks (SNBs) are integral components of multimodal analgesia.
Recent research in the adult population has shown that multimodal analgesic strategies in arthroscopic surgeries can significantly reduce postoperative opioid consumption and improve quality of recovery.
In 2000, following the creation and initial clinical use of a 9-item Quality of Recovery (QoR) score, some authors introduced the 40-item QoR-40 and the shorter QoR-15. The QoR-15 scale provides a comprehensive assessment of postoperative recovery, with scores ranging from 0 (very poor QoR) to 150 (excellent QoR). Since then, the QoR-15 has emerged as the most commonly reported measure of patient-assessed quality of recovery after surgery, validated in the adult population.
The investigators plan to perform a prospective randomized controlled feasibility study comparing preoperative single-shot ACB to non-block in pediatric patients undergoing ambulatory arthroscopic ACL reconstruction. The investigators hypothesize that patients who received ACB preoperatively would have improved analgesia, fewer opioid-related adverse effects, greater patient satisfaction, and shorter PACU recovery times. Feasibility will be determined by enrollment rate, defined as the proportion of participants enrolled over the number of participants approached. We will declare feasibility if the enrollment rate is ≥ 80%.The primary clinical outcome variable is improvement in QoR-15 scores on POD2, POD14 and POD42.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 38 is below the median of 65 across 128 interventional studies indexed under Lacerations.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
The local anesthetic (ropivacaine) + dexmedetomidine will be administered via single-shot adductor canal block under ultrasound guidance
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,
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
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%.
Time frame: Period of recruitment is expected to be 12 months
Pain control
Patient will report pain on an 11-item numerical rating scale, where 0 = no pain and 10 = worst pain imaginable
Time frame: 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
Duration of stay in post-anesthetic care unit, in minutes
Time frame: 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
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.
Time frame: Day of surgery to postoperative day 14. Includes opioids used intraoperatively, in post-anesthetic care unit, and post-discharge.
Patient Satisfaction
Patient asked to rate satisfaction regarding pain management on a 5-item scale, ranging from Very dissatisfied to Very satisfied
Time frame: 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
Caregiver is asked to rate satisfaction regarding pain management on a 5-item scale, ranging from Very dissatisfied to Very satisfied
Time frame: From day of surgery to postoperative day 42. Caregiver is asked to rate satisfaction on day of surgery and again on postoperative day 42
Hospital admission for any reason
Hospital admission for any reason (yes/no) will be recorded from electronic medical record and from interview with patient
Time frame: Day of surgery until postoperative day 42
Plan to share: Yes — Deidentified data will be provided by PI on reasonable request once the data have been analyzed and published in a peer-reviewed journal
Supporting information: 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.
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