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?

This trial investigates whether adding a special pain relief technique, called an adductor canal block, to standard anesthesia can improve recovery after knee surgery for ACL tears in children and teens. The adductor canal block uses Ropivacaine and Dexmedetomidine (a local anesthetic and a sedative, respectively) to provide pain relief. The goal is to determine if this technique can lead to better recovery scores, reduced need for painkillers, and greater patient satisfaction. Participants will be randomly assigned to receive either this additional pain relief or just the usual anesthesia. Children and teens aged 10-18 who are scheduled for ACL surgery and consent to the procedure and follow-ups are potential candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in pain management.

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 there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that adding dexmedetomidine to ropivacaine in adductor canal blocks (a type of nerve block) can be safe and effective for pain management. In earlier studies, patients who received this combination needed less pain medication after surgery and waited longer before requesting pain relief, suggesting effective pain management.

Regarding safety, many patients have used the combination of ropivacaine and dexmedetomidine without significant serious side effects, indicating it is generally well-tolerated.

Since this trial is in the later stages, earlier studies must have found the treatment safe enough for further testing. If the FDA has approved this treatment for other uses, it suggests potential safety. However, discussing all potential risks with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using an adductor canal block with ropivacaine and dexmedetomidine for ACL tears because it offers targeted pain relief with potentially fewer side effects. Unlike traditional treatments like oral painkillers or systemic nerve blocks, this method focuses on numbing specific nerves in the leg, which could lead to better pain control and quicker recovery. Additionally, dexmedetomidine, used in this combination, enhances the effects of ropivacaine, potentially prolonging pain relief without increasing overall medication dosage. This approach could revolutionize pain management for ACL injuries, offering patients a more effective and comfortable recovery experience.

What evidence suggests that the adductor canal block is effective for ACL tear recovery?

In this trial, participants will be divided into two groups to evaluate pain management after ACL reconstruction. One group will receive a single-shot adductor canal block using ropivacaine combined with dexmedetomidine, while the other group will not receive a nerve block. Research has shown that using ropivacaine with dexmedetomidine in a nerve block can greatly improve pain relief after surgery. Studies have found that this combination delays the need for pain medication like tramadol and reduces the total amount of painkillers needed after surgery. As a result, patients experience better pain control and a more comfortable recovery. This method is particularly effective for managing pain after surgeries like ACL reconstruction, aiding smoother recovery. Overall, evidence suggests that this treatment may lead to better pain management and faster recovery times. ^{1 2 3 6 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6463348/

Evaluation of analgesic efficacy of dexmedetomidine as ... Evaluation of analgesic efficacy of dexmedetomidine as adjuvant with ropivacaine in ultrasound-guided adductor canal block in patients following ...

2. journals.lww.com journals.lww.com/bjoa/fulltext/2022/06010/dexmedetomidine_and_clonidine_as_adjuvants_to.5.aspx

Dexmedetomidine and Clonidine as Adjuvants to ... Dexmedetomidine, when added as an adjuvant to 0.5% ropivacaine in ACB, leads to increased time to first request of tramadol, reduced postoperative tramadol ...

3. ijmedph.org ijmedph.org/Uploads/Volume15Issue1/171.%20[1613.%20IJMEDPH_Devika]%20914-920.pdf

effect of dexmedetomidine as adjuvant to ropivacaine in ... The aim was to study the effect of dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided adductor canal block for postoperative analgesia following ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/2049463718796865

Evaluation of analgesic efficacy of dexmedetomidine as ... Evaluation of analgesic efficacy of dexmedetomidine as adjuvant with ropivacaine in ultrasound-guided adductor canal block in patients following anterior ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06875427

ACB vs no Block for Pediatric 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 ...

6. nature.com nature.com/articles/s41598-025-94343-0.pdf

Ultrasound guided proximal adductor canal and pes ... This study aims to investigate the impact of combined proximal adductor canal and pes anserinus tendon block on early recovery after anterior cruciate ligament ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11626880/

Adductor canal block (ACB) plus infiltration of the posterior ... The 4-in-1 block provides non-inferior analgesia compared to the established iPACK plus ACB for arthroscopic ACL surgery.