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

NCT06952556 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-01855
• Study Type: interventional
• Target: 100
• 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 high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy (TTO).

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Opioid Utilization for First 24 Hours Post-Surgery

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

  Up to Hour 24 Post-Procedure (Post-Operative Day 1 [POD 1])

Secondary Outcomes (14)

• Length of Stay in PACU

  Post-Operation (POD 0 - typically up to 3 hours)

• Patient-Reported Visual Analogue Scale (VAS) Score - Baseline

  Baseline

• Patient-Reported VAS Score in Post-Anesthesia Care Unit (PACU)

  Post-Operation (POD 0 - typically up to 3 hours)

• Patient-Reported VAS Score - Post-Operative Day 1 (POD 1)

  POD 1

• Patient-Reported VAS Score - Post-Operative Day 2 (POD 2)

  POD 2

Study Arms (2)

Adductor Canal Block (ACB) + IPACK Block

EXPERIMENTAL

Participants receive ACB with IPACK block.

Drug: ACB; Drug: IPACK block

Isolated Adductor Canal Block

ACTIVE COMPARATOR

Participants receive ACB only.

Drug: ACB

Interventions

ACB DRUG

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

Adductor Canal Block (ACB) + IPACK Block; Isolated Adductor Canal Block

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

Adductor Canal Block (ACB) + 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 HTO/DFO/TTO.
• American Society of Anesthesiologists (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 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;

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laith Jazrawi, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laith Jazrawi, MD

CONTACT

646-501-7223; Laith.jazrawi@nyulangone.org

Study Design

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

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 1, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): June 28, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)