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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
102
IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee
NYU Langone Health
New York, New York, United States
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.
Time frame: Up to Hour 24 Post-Operation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: Day 7 Post-Operation
Length of Stay in Post-Anesthesia Care Unit (PACU)
Measured by the length of stay after surgery (minutes)
Time frame: Up to Day 1 Post-Operation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 6 Post-Operation Visit