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

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 HTO/DFO/TTO

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).

Study Overview

• Status: Recruiting
• Conditions: Analgesia
• Intervention / Treatment: Drug: IPACK block; Drug: ACB

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Laith Jazrawi, MD; Phone Number: 646-501-7223; Email: Laith.jazrawi@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adductor Canal Block (ACB) + IPACK Block; Participants receive ACB with IPACK block.	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; Drug: ACB; 15 mL of 0.25% Bupivacaine block of the saphenous nerve injected under ultrasound guidance via adductor canal.
Active Comparator: Isolated Adductor Canal Block; Participants receive ACB only.	Drug: ACB; 15 mL of 0.25% Bupivacaine block of the saphenous nerve injected under ultrasound guidance via adductor canal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay in PACU	Length of time the patient is in the PACU prior to discharge.	Post-Operation (POD 0 - typically up to 3 hours)
Patient-Reported Visual Analogue Scale (VAS) Score - Baseline	Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.	Baseline
Patient-Reported VAS Score in Post-Anesthesia Care Unit (PACU)	Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.	Post-Operation (POD 0 - typically up to 3 hours)
Patient-Reported VAS Score - Post-Operative Day 1 (POD 1)	Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.	POD 1
Patient-Reported VAS Score - Post-Operative Day 2 (POD 2)	Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.	POD 2
Patient-Reported VAS Score - Post-Operative Day 3 (POD 3)	Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.	POD 3
Patient-Reported VAS Score - Post-Operative Day 7 (POD 7)	Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.	POD 7
Patient-Reported VAS Score - Month 6 Follow-Up	Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.	Month 6 Post-Operation
Knee injury and Osteoarthritis Outcome Score (KOOS) - Physical Function Shortform (KOOS-PS) Score - Baseline	7-item assessment of how well participants are able to perform different activities. Each item is rated on a 5-point Likert scale (0 to 4), with 0 representing "none" and 4 representing "extreme". The raw score is the sum of responses and is converted to a total score ranging from 0-100, where higher scores indicate greater function.	Baseline
KOOS-PS Score - Month 6 Follow-Up	7-item assessment of how well participants are able to perform different activities. Each item is rated on a 5-point Likert scale (0 to 4), with 0 representing "none" and 4 representing "extreme". The raw score is the sum of responses and is converted to a total score ranging from 0-100, where higher scores indicate greater function.	Month 6 Post-Operation
Kujala Score / Anterior Knee Pain Scale (AKPS) - Baseline	13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The total score is the sum of responses and ranges from 0 to 100, with 100 being the highest possible score. Lower scores reflect greater pain and disability.	Baseline
Kujala Score / AKPS - Month 6 Follow-Up	13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The total score is the sum of responses and ranges from 0 to 100, with 100 being the highest possible score. Lower scores reflect greater pain and disability.	Month 6 Post-Operation
Tegner Activity Scale (TAS) Score - Baseline	The Tegner Activity Scale (TAS) is a 1-item, self-administered questionnaire used to assess a patient's ability to engage in work and sports activities. The item is rated on a scale of 0 to 10, with 0 representing maximum disability and 10 representing elite sports participation. The total score is the item response.	Baseline
Tegner Activity Scale (TAS) Score - Month 6 Follow-Up	The Tegner Activity Scale (TAS) is a 1-item, self-administered questionnaire used to assess a patient's ability to engage in work and sports activities. The item is rated on a scale of 0 to 10, with 0 representing maximum disability and 10 representing elite sports participation. The total score is the item response.	Month 6 Post-Operation

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Laith Jazrawi, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): June 28, 2027

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: 24-01855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Investigators will not be sharing this information with other researchers beyond publishing our findings in a scientific journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes