Anterior Cruciate LigamentPhase 3NCT06875427
ACB vs no Block for Pediatric ACL Reconstruction
A Phase 3 study testing Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidance in people with Anterior Cruciate Ligament and Anterior Cruciate Ligament (ACL) Tear, run by Isabella Jaramillo at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Anterior Cruciate Ligament, Anterior Cruciate Ligament (ACL) Tear
- What is being tested?
- Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2025to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients ASA I, II and III
- 10-18 years of age
- scheduled for ACL reconstruction
- agreeable to regional block and follow-ups
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster Children's Hospital, Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
2894569400
About this study
Official title: Comparing Preoperative Adductor Canal vs. No Block for Quality of Recovery After Anterior Cruciate Ligament Reconstruction in Patients Younger Than 18 Years of Age: A Randomized Controlled Feasibility 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).
Read the detailed description
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.
- Being tested
- Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidance
- Keywords
- single-shot adductor canal block, anterior cruciate ligament reconstruction
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidanceDrug
The local anesthetic (ropivacaine) + dexmedetomidine will be administered via single-shot adductor canal block under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Single-shot adductor canal block | Experimental | 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. Receives: Drug: Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidance |
| Non-block | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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%.
Measured: Period of recruitment is expected to be 12 months
Secondary outcomes (6)
Pain control
Patient will report pain on an 11-item numerical rating scale, where 0 = no pain and 10 = worst pain imaginable
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Day of surgery until postoperative day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Jul 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate LigamentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled feasibility study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isabella Jaramillo
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor-investigator, Isabella Jaramillo, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875427
- Sponsor's protocol ID
- ssACB2024
- Status last verified
- Sep 2025
- First submitted
- 27 Nov 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be provided by PI on reasonable request once the data have been analyzed and published in a peer-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Preoperative Adductor Canal vs. No Block for Quality of Recovery After Anterior Cruciate Ligament Reconstruction in Patients Younger Than 18 Years of Age: A Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT06875427
- Acronym / sponsor ID
- ssACB2024
- Keywords
- single-shot adductor canal block, anterior cruciate ligament reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Isabella JaramilloUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled feasibility study
| Arm | Type | Receives |
|---|---|---|
| Single-shot adductor canal block | Experimental | Drug: Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidanceAll 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. |
| Non-block | No intervention | –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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients ASA I, II and III
- 10-18 years of age
- scheduled for ACL reconstruction
- agreeable to regional block and follow-ups
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidanceThe local anesthetic (ropivacaine) + dexmedetomidine will be administered via single-shot adductor canal block under ultrasound guidance | Drug | Single-shot adductor canal block |
Primary outcome
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
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
Time frame: Period of recruitment is expected to be 12 months
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%.
6 secondary outcomes
Pain control
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
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
Time frame: Day of surgery to postoperative day 14. Includes opioids used intraoperatively, in post-anesthetic care unit, and post-discharge.
Patient Satisfaction
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
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
Time frame: Day of surgery until postoperative day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: Yes. Deidentified data will be provided by PI on reasonable request once the data have been analyzed and published in a peer-reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine 2-2.5mg/kg + dexmedetomidine 1 mcg/kg delivered via a single-shot adductor canal block under ultrasound guidance in people with Anterior Cruciate Ligament and Anterior Cruciate Ligament (ACL) Tear, run by Isabella Jaramillo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabella Jaramillo, MD (905-379-9241, jaramilc@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.