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Analgesia Technique for ACL Injury

Phase 4
Waitlist Available
Led By Jonathan Beathe, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 13 or greater
Patients undergoing BTB ACL reconstruction with participating surgeon
Must not have
Hepatic or renal insufficiency
Patients undergoing general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 3 hours post-block administration on post-operative day (pod) 0 until met discharge criteria, assessed up to 1 day
Awards & highlights

Summary

This trial found that the addition of local anesthetic infiltration to an adductor canal block (ACB) did not improve postoperative pain control or functional outcomes in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.

Who is the study for?
This trial is for individuals aged 13 or older who are undergoing bone-tendon-bone ACL reconstruction and can follow the study protocol. Participants must speak English, plan to use regional anesthesia, and not have liver or kidney issues, allergies to study meds, diabetes, severe systemic disease (ASA IV), chronic opioid/gabapentin/pregabalin use, a BMI over 40, or be non-English speaking.
What is being tested?
The trial compares two anesthetic techniques in patients having ACL surgery: Adductor Canal Block (ACB) alone versus ACB with additional infiltration between the popliteal artery and knee capsule (ACB/IPACK). It aims to determine which method provides better pain control during recovery.
What are the potential side effects?
Potential side effects may include discomfort at injection sites, possible nerve damage from needle placement under ultrasound guidance, allergic reactions to Bupivacaine or Dexamethasone used in blocks, and typical risks associated with anesthesia such as nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 13 years old or older.
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I am having BTB ACL surgery with a surgeon in the study.
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I will be receiving regional anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver or kidneys are not working properly.
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I will be undergoing surgery with general anesthesia.
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I am under 13 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 3 hours post-block administration on post-operative day (pod) 0 until met discharge criteria, assessed up to 1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 3 hours post-block administration on post-operative day (pod) 0 until met discharge criteria, assessed up to 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain While at Rest
Secondary study objectives
Discharge Criteria
Pain With Ambulation

Trial Design

2Treatment groups
Active Control
Group I: Adductor Canal Block (ACB)Active Control3 Interventions
The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
Group II: Adductor Canal Block & IPACK (ACB/IPACK)Active Control3 Interventions
The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation. The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
249 Previous Clinical Trials
61,251 Total Patients Enrolled
2 Trials studying Anterior Cruciate Ligament Injury
58 Patients Enrolled for Anterior Cruciate Ligament Injury
Jonathan Beathe, MDPrincipal InvestigatorHospital for Special Surgery, New York

Media Library

Anterior Cruciate Ligament Injury Clinical Trial 2023: Adductor Canal Block (ACB) Highlights & Side Effects. Trial Name: NCT03292926 — Phase 4
~10 spots leftby Sep 2025
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