Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:

Phase 4

Completed

Conditions: Anterior Cruciate Ligament Rupture

Interventions: Drug: IPACK block

Registration Number: NCT05286307

Lead Sponsor: NYU Langone Health

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

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;

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants receiving IPACK block	IPACK block	Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee.

Primary Outcome Measures

Name	Time	Method
Opioid Utilization in First 24 Hours Post-Surgery	Up to Hour 24 Post-Operation	Opioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported VAS Scores at 48 Hours Post-Surgery	Hour 48 Post-Operation	VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery	Hour 24 Post-Operation	VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score ranges from 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Patient-Reported VAS Scores at Day 7 Post-Surgery	Day 7 Post-Operation	VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Change in Tegner Activity Scale (TAS) Score	Baseline, Month 6 Post-Operation Visit	The TAS asks participants to indicate the highest level of activity they are able to participate in at the time of the survey. The options range from Level 10 (competitive sports on a national elite level) to Level 0 (sick leave or disability pension because of knee problems). The total score corresponds with the selected Level and ranges from 0-10; higher scores indicate higher levels of activity.
Change of Range of Motion (ROM) Assessment	Baseline, Month 6 Post-Operation Visit	A Range of Motion (ROM) assessment is most commonly used to measure movement of the ankles, knees, hips, shoulders, elbows, wrists and fingers. Measures of knee ROM will be taken at baseline and Month 6 to assess the change in ROM over time.
Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)	Baseline, Month 6 Post-Operation Visit	The KOOS-PS is a 7-item measure of physical functional derived from the items of the Function, daily living and Function, sports and recreational activity subscales of the KOOS. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The raw score is calculated by summing the responses and ranges from 0-28. The raw score is converted to a true interval score ranging from 0-100, where higher scores indicate greater physical function.
Patient-Reported VAS Scores at 72 Hours Post-Surgery	Hour 72 Post-Operation	VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Length of Stay in Post-Anesthesia Care Unit (PACU)	Up to Day 1 Post-Operation	Measured by the length of stay after surgery (minutes)
Change in Kujala Scale Score	Baseline, Month 6 Post-Operation Visit	Knee pain will be measured by self reported Kujala scale. The Kujala Scale is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). The total score ranges from 0 to 100; higher scores indicate lesser knee pain.