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NCT Number: NCT06952556

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ACB

Drug

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

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

Primary outcomes

  1. Opioid Utilization for First 24 Hours Post-Surgery

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

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

Secondary outcomes

  1. Length of Stay in PACU

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

    Length of time the patient is in the PACU prior to discharge.

  2. Patient-Reported Visual Analogue Scale (VAS) Score - Baseline

    Time frame: 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.

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

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

    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.

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

    Time frame: 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.

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

    Time frame: 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.

  6. Patient-Reported VAS Score - Post-Operative Day 3 (POD 3)

    Time frame: 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.

  7. Patient-Reported VAS Score - Post-Operative Day 7 (POD 7)

    Time frame: 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.

  8. Patient-Reported VAS Score - Month 6 Follow-Up

    Time frame: Month 6 Post-Operation

    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.

  9. Knee injury and Osteoarthritis Outcome Score (KOOS) - Physical Function Shortform (KOOS-PS) Score - Baseline

    Time frame: 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.

  10. KOOS-PS Score - Month 6 Follow-Up

    Time frame: Month 6 Post-Operation

    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.

  11. Kujala Score / Anterior Knee Pain Scale (AKPS) - Baseline

    Time frame: 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.

  12. Kujala Score / AKPS - Month 6 Follow-Up

    Time frame: Month 6 Post-Operation

    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.

  13. Tegner Activity Scale (TAS) Score - Baseline

    Time frame: 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.

  14. Tegner Activity Scale (TAS) Score - Month 6 Follow-Up

    Time frame: Month 6 Post-Operation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laith Jazrawi, MD

CONTACT

[email protected]

646-501-7223

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 1, 2025
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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