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Recruiting NCT06952556

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

Phase IV Interventional Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACB, IPACK block.
Who it may be relevant to
Registry conditions: Analgesia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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).

Interventions

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

Primary outcome measures

  • Opioid Utilization for First 24 Hours Post-Surgery [Time frame: Up to Hour 24 Post-Procedure (Post-Operative Day 1 [POD 1])]
Secondary outcome measures (12)
  • Length of Stay in PACU [Time frame: Post-Operation (POD 0 - typically up to 3 hours)]
  • Patient-Reported Visual Analogue Scale (VAS) Score - Baseline [Time frame: Baseline]
  • Patient-Reported VAS Score in Post-Anesthesia Care Unit (PACU) [Time frame: Post-Operation (POD 0 - typically up to 3 hours)]
  • Patient-Reported VAS Score - Post-Operative Day 1 (POD 1) [Time frame: POD 1]
  • Patient-Reported VAS Score - Post-Operative Day 2 (POD 2) [Time frame: POD 2]
  • Patient-Reported VAS Score - Post-Operative Day 3 (POD 3) [Time frame: POD 3]
  • Patient-Reported VAS Score - Post-Operative Day 7 (POD 7) [Time frame: POD 7]
  • Patient-Reported VAS Score - Month 6 Follow-Up [Time frame: Month 6 Post-Operation]
  • Knee injury and Osteoarthritis Outcome Score (KOOS) - Physical Function Shortform (KOOS-PS) Score - Baseline [Time frame: Baseline]
  • KOOS-PS Score - Month 6 Follow-Up [Time frame: Month 6 Post-Operation]
  • Kujala Score / Anterior Knee Pain Scale (AKPS) - Baseline [Time frame: Baseline]
  • Kujala Score / AKPS - Month 6 Follow-Up [Time frame: Month 6 Post-Operation]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06952556 · 24-01855

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗