Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:

NCT05286307 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 22-00148
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• Opioid Utilization in First 24 Hours Post-Surgery

  Opioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent.

  Up to Hour 24 Post-Operation

Secondary Outcomes (9)

• Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery

  Hour 24 Post-Operation

• Patient-Reported VAS Scores at 48 Hours Post-Surgery

  Hour 48 Post-Operation

• Patient-Reported VAS Scores at 72 Hours Post-Surgery

  Hour 72 Post-Operation

• Patient-Reported VAS Scores at Day 7 Post-Surgery

  Day 7 Post-Operation

• Length of Stay in Post-Anesthesia Care Unit (PACU)

  Up to Day 1 Post-Operation

Study Arms (2)

Participants receiving IPACK block

EXPERIMENTAL

Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee.

Drug: IPACK block

Standard of care group

NO INTERVENTION

Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).

Interventions

IPACK block DRUG

IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee

Participants receiving IPACK block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 75 years of age
• Patients undergoing primary ACL reconstruction with BPTB Autograft
• ASA I or II

You may not qualify if:

• Patients younger than 18 and older than 75.
• Patients with multi-ligament injury
• Patients undergoing concomitant cartilage procedure or osteotomy.
• Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer.
• Patients who are allergic to oxycodone;
• Patients with diagnosed or self-reported cognitive dysfunction;
• Patients with a history of neurologic disorder that can interfere with pain sensation;
• Patients with a history of drug or recorded alcohol abuse;
• Patients who are unable to understand or follow instructions;
• Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
• Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
• Patients with a BMI over 45;
• Any patient that the investigators feel cannot comply with all study related procedures;
• Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Rao N, Triana J, Avila A, Campbell KA, Alaia MJ, Jazrawi LM, Furiguele D, Popovic J, Strauss EJ. Postoperative Pain and Opioid Usage With Combined Adductor Canal and IPACK Block Versus Isolated Adductor Canal Block After Anterior Cruciate Ligament Reconstruction With a Bone-Patellar Tendon-Bone Autograft: A Single-Center Randomized Controlled Trial. Am J Sports Med. 2025 May;53(6):1359-1367. doi: 10.1177/03635465251328609. Epub 2025 May 1.

  PMID: 40308075 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Eric J Strauss, MD
• Organization: NYU Langone Health

Eric.Strauss@nyulangone.org

646 501-7223

Study Officials

• Eric J Strauss, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: July 11, 2022
• Primary Completion: March 31, 2023
• Study Completion: December 18, 2023
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)