Adductor Canal Block for ACL Tear

Overseen By Isabella Jaramillo, MD

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Isabella Jaramillo

Disqualifiers: Coagulopathies, Neurologic deficit, Cognitive deficit, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the combination of Ropivacaine and Dexmedetomidine safe for use in humans?

Studies show that using Ropivacaine with Dexmedetomidine for pain relief in surgeries like knee replacements and ACL reconstructions is generally safe, with no reports of serious side effects like bradycardia (slow heart rate) or hypotension (low blood pressure). ^{1 2 3 4 5}

How does the adductor canal block differ from other treatments for ACL tear?

The adductor canal block for ACL tear is unique because it uses a combination of ropivacaine, a local anesthetic, and dexmedetomidine, an alpha-2 agonist, to provide pain relief while preserving muscle strength. This approach allows for effective pain management with a lower concentration of anesthetic, reducing potential side effects compared to other treatments. ^{1 2 3 4 6}

What data supports the effectiveness of the drug Ropivacaine + Dexmedetomidine for ACL tear?

Research shows that adding dexmedetomidine to ropivacaine in an adductor canal block can reduce the amount of ropivacaine needed for effective pain relief, which suggests that this combination may enhance pain management after surgeries like ACL reconstruction. ^{1 2 3 4 7}

Are You a Good Fit for This Trial?

This trial is for pediatric patients needing ACL reconstruction surgery. Participants must be suitable for both general anesthesia and the specific nerve block being tested. The study excludes those with contraindications to the medications used or who cannot follow up.

Inclusion Criteria

My health is good to moderately impaired.

I agree to have a regional block and attend all follow-up visits.

I am scheduled for ACL surgery.

Exclusion Criteria

I have other serious health issues that could affect my recovery or participation.

I refuse to undergo regional techniques.

I cannot have an adductor canal block due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive a standardized general anesthetic technique, with or without a single-shot adductor canal block

Day of surgery

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain management and recovery quality using the QoR-15 questionnaire at multiple timepoints

6 weeks

4 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including satisfaction and pain management assessments

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine + Dexmedetomidine

Trial Overview The study tests if adding a single-shot adductor canal block with Ropivacaine and dexmedetomidine to standard care improves recovery compared to no regional technique. It measures pain, opioid use, PACU stay length, satisfaction, and recovery scores.

How Is the Trial Designed?

Group I: Single-shot adductor canal block Experimental Treatment 1 Intervention

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.

Group II: Non-block Active Control 1 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 Is Running the Clinical Trial?

Isabella Jaramillo

Lead Sponsor

Trials

1

Recruited

40+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of analgesic efficacy of dexmedetomidine as adjuvant with ropivacaine in ultrasound-guided adductor canal block in patients following anterior cruciate ligament reconstruction surgeries. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Perineural Dexmedetomidine Reduces the Median Effective Concentration of Ropivacaine for Adductor Canal Block. [2021]

3. Brazil pubmed.ncbi.nlm.nih.gov

[Comparison of adductor canal block for analgesia in arthroscopic surgery with ropivacaine alone and ropivacaine and clonidine]. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Adductor canal block for post-operative analgesia after simultaneous bilateral total knee replacement: A randomised controlled trial to study the effect of addition of dexmedetomidine to ropivacaine. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Minimum effective concentration of ropivacaine for ultrasound-guided adductor canal + IPACK block in total knee arthroplasty. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Does Treatment with Dexmedetomidine Intra-articularly Improve Postoperative Pain and Rehabilitation after Anterior Cruciate Ligament Reconstruction? [2022]

7. Greece pubmed.ncbi.nlm.nih.gov

Efficacy of perineural dexamethasone with ropivacaine in adductor canal block for post-operative analgesia in patients undergoing total knee arthroplasty: A randomized controlled trial. [2020]