Back to resultsAdductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:
Primary Purpose
Anterior Cruciate Ligament Rupture
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IPACK block
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Rupture
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;
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Participants receiving IPACK block
Standard of care group
Arm Description
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.
Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
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 10 (worst pain imaginable); the higher the score, the worse the pain.
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 10 (worst pain imaginable); the higher the score, the worse the pain.
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 10 (worst pain imaginable); the higher the score, the worse the pain.
Length of stay in Post-Anesthesia Care Unit (PACU)
Measured by the length of stay after surgery.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05286307
Brief 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:
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants receiving IPACK block
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care group
Arm Type
No Intervention
Arm Description
Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Intervention Type
Drug
Intervention Name(s)
IPACK block
Intervention Description
IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee
Primary Outcome Measure Information:
Title
Opioid Utilization in First 24 Hours Post-Surgery
Description
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
Secondary Outcome Measure Information:
Title
Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery
Description
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 10 (worst pain imaginable); the higher the score, the worse the pain.
Time Frame
Hour 24 Post-Operation
Title
Patient-Reported VAS Scores at 48 Hours Post-Surgery
Description
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 10 (worst pain imaginable); the higher the score, the worse the pain.
Time Frame
Hour 48 Post-Operation
Title
Patient-Reported VAS Scores at 72 Hours Post-Surgery
Description
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 10 (worst pain imaginable); the higher the score, the worse the pain.
Time Frame
Hour 72 Post-Operation
Title
Patient-Reported VAS Scores at Day 7 Post-Surgery
Description
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 10 (worst pain imaginable); the higher the score, the worse the pain.
Time Frame
Day 7 Post-Operation
Title
Length of stay in Post-Anesthesia Care Unit (PACU)
Description
Measured by the length of stay after surgery.
Time Frame
Up to Day 1 Post-Operation
Title
Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)
Description
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
Title
Change in Kujala Scale Score
Description
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
Title
Change in Tegner Activity Scale (TAS) Score
Description
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
Title
Change of Range of Motion (ROM) Assessment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Strauss, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will be maintained in an encrypted REDCap database to be accessed only by the principal investigator and study team members
Learn more about this trial
Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:
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