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

Anterior Cruciate Ligament Rupture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05286307
• Other study ID #: 22-00148
• Status: Completed
• Phase: Phase 4
• Start date: July 11, 2022
• Est. completion date: December 18, 2023

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 18, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of Stay in Post-Anesthesia Care Unit (PACU)	Measured by the length of stay after surgery (minutes)	Up to Day 1 Post-Operation
Secondary	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
Secondary	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
Secondary	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
Secondary	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