Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following HTO/DFO/TTO

NCT ID: NCT06952556

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-28
• Study Completion Date: 2027-06-28

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 high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy (TTO).

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Adductor Canal Block (ACB) + IPACK Block

Participants receive ACB with IPACK block.

Group Type: EXPERIMENTAL

ACB

Intervention Type: DRUG

15 mL of 0.25% Bupivacaine block of the saphenous nerve injected under ultrasound guidance via adductor canal.

IPACK block

Intervention Type: DRUG

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

Isolated Adductor Canal Block

Participants receive ACB only.

Group Type: ACTIVE_COMPARATOR

ACB

Intervention Type: DRUG

15 mL of 0.25% Bupivacaine block of the saphenous nerve injected under ultrasound guidance via adductor canal.

Interventions

ACB

15 mL of 0.25% Bupivacaine block of the saphenous nerve injected under ultrasound guidance via adductor canal.

Intervention Type: DRUG

IPACK block

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients between 18 and 75 years of age
• Patients undergoing HTO/DFO/TTO.
• American Society of Anesthesiologists (ASA) I or II

Exclusion Criteria

• Patients younger than 18 and older than 75.
• Patients with multi-ligament injury
• Patients undergoing concomitant cartilage procedure or ACLR.
• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laith Jazrawi, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Central Contacts

Laith Jazrawi, MD

Role: CONTACT

Laith.jazrawi@nyulangone.org

646-501-7223

Other Identifiers

24-01855

Identifier Type: -

Identifier Source: org_study_id