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

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

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

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Drug: IPACK block

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

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants receiving 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.	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
No Intervention: Standard of care group; Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)	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.	Baseline, Month 6 Post-Operation Visit
Change in Kujala Scale Score	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.	Baseline, Month 6 Post-Operation Visit
Change in Tegner Activity Scale (TAS) Score	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.	Baseline, Month 6 Post-Operation Visit
Change of Range of Motion (ROM) Assessment	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.	Baseline, Month 6 Post-Operation Visit
Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery	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.	Hour 24 Post-Operation
Patient-Reported VAS Scores at 48 Hours Post-Surgery	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.	Hour 48 Post-Operation
Patient-Reported VAS Scores at 72 Hours Post-Surgery	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.	Hour 72 Post-Operation
Patient-Reported VAS Scores at Day 7 Post-Surgery	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.	Day 7 Post-Operation
Length of Stay in Post-Anesthesia Care Unit (PACU)	Measured by the length of stay after surgery (minutes)	Up to Day 1 Post-Operation

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Eric J Strauss, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 22-00148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will be maintained in an encrypted REDCap database to be accessed only by the principal investigator and study team members

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No