Clinical trial NCT06952556: Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following HTO/DFO/TTO
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Analgesia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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;

Primary outcomes:
measure: Opioid Utilization for First 24 Hours Post-Surgery
timeFrame: Up to Hour 24 Post-Procedure (Post-Operative Day 1 [POD 1])
Secondary outcomes:
measure: Length of Stay in PACU
timeFrame: Post-Operation (POD 0 - typically up to 3 hours)
measure: Patient-Reported Visual Analogue Scale (VAS) Score - Baseline
timeFrame: Baseline
measure: Patient-Reported VAS Score in Post-Anesthesia Care Unit (PACU)
timeFrame: Post-Operation (POD 0 - typically up to 3 hours)
measure: Patient-Reported VAS Score - Post-Operative Day 1 (POD 1)
timeFrame: POD 1
measure: Patient-Reported VAS Score - Post-Operative Day 2 (POD 2)
timeFrame: POD 2
measure: Patient-Reported VAS Score - Post-Operative Day 3 (POD 3)
timeFrame: POD 3
measure: Patient-Reported VAS Score - Post-Operative Day 7 (POD 7)
timeFrame: POD 7
measure: Patient-Reported VAS Score - Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - Physical Function Shortform (KOOS-PS) Score - Baseline
timeFrame: Baseline
measure: KOOS-PS Score - Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: Kujala Score / Anterior Knee Pain Scale (AKPS) - Baseline
timeFrame: Baseline
measure: Kujala Score / AKPS - Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
measure: Tegner Activity Scale (TAS) Score - Baseline
timeFrame: Baseline
measure: Tegner Activity Scale (TAS) Score - Month 6 Follow-Up
timeFrame: Month 6 Post-Operation
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Laith Jazrawi, MD
role: PRINCIPAL_INVESTIGATOR
References: