Clinical trial NCT05286307: Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:
Official title: Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft: A Single Center Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 102
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: TREATMENT

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 ACL reconstruction with Bone Patellar Tendon Bone Autograft

Detailed description: The protocol will determine if the addition of an IPACK block to the standard adductor canal block is superior to an isolated adductor canal block in controlling post-operative pain and decreasing postoperative opioid consumption in patients undergoing ACLR with Bone Patellar Tendon Bone Autograft

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 75 years of age
* Patients undergoing primary ACL reconstruction with BPTB Autograft
* 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 osteotomy.
* 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 in First 24 Hours Post-Surgery
timeFrame: Up to Hour 24 Post-Operation
Secondary outcomes:
measure: Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery
timeFrame: Hour 24 Post-Operation
measure: Patient-Reported VAS Scores at 48 Hours Post-Surgery
timeFrame: Hour 48 Post-Operation
measure: Patient-Reported VAS Scores at 72 Hours Post-Surgery
timeFrame: Hour 72 Post-Operation
measure: Patient-Reported VAS Scores at Day 7 Post-Surgery
timeFrame: Day 7 Post-Operation
measure: Length of Stay in Post-Anesthesia Care Unit (PACU)
timeFrame: Up to Day 1 Post-Operation
measure: Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)
timeFrame: Baseline, Month 6 Post-Operation Visit
measure: Change in Kujala Scale Score
timeFrame: Baseline, Month 6 Post-Operation Visit
measure: Change in Tegner Activity Scale (TAS) Score
timeFrame: Baseline, Month 6 Post-Operation Visit
measure: Change of Range of Motion (ROM) Assessment
timeFrame: Baseline, Month 6 Post-Operation Visit
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eric J Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References: