Back to resultsiPACK for Post-op Pain Following ACL Reconstruction
Primary Purpose
ACL Injury, Post Operative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Adductor Canal Block (ACB) Only
Adductor Canal Block (ACB) + iPACK Block
Sponsored by
About this trial
This is an interventional treatment trial for ACL Injury focused on measuring acl injury, acl repair
Eligibility Criteria
Inclusion Criteria:
- Age 12 years and older
- Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.
Exclusion Criteria:
- Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury.
- Patients undergoing hamstring graft or allograft for ACL
- Pre-existing infection at the site of injury
- Patients on chronic opioid treatments
- Pre-existing sensory or motor deficit in operative extremity
- Patients having a revision of previous ACL reconstruction
- Pregnant and/or lactating women
- Weighs less than 40kg
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Adductor Canal Block (ACB) Only
ACB + iPACK
Arm Description
Participants randomized to the ACB only group will receive an adductor canal block alone.
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Outcomes
Primary Outcome Measures
Pain Scores
The primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome.
Secondary Outcome Measures
total postoperative opioid consumption (total MME)
The secondary endpoints will measure total perioperative opioid consumption through postoperative day 2
Range of Motion (degrees)
An additional secondary endpoint is the range of motion, measured in degrees, of the operative knee at post-op visit 1 and 2. The post-op measurements will be compared to the pre-operative measurements.
Terminal knee extension (degrees)
The third secondary endpoint is the terminal knee extension, measured in degrees, of the operative knee at post-op visit 1 and 2. The post-op measurements will be compared to the pre-operative measurements.
Full Information
NCT ID
NCT05498870
First Posted
July 27, 2022
Last Updated
October 2, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05498870
Brief Title
iPACK for Post-op Pain Following ACL Reconstruction
Official Title
Studying the Effects of iPACK Blocks With Adductor Canal Blocks for Postoperative Analgesia Following ACL Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
July 3, 2023 (Actual)
Study Completion Date
August 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
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
This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, Post Operative Pain
Keywords
acl injury, acl repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Only the patient will be blinded to the treatment group.
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adductor Canal Block (ACB) Only
Arm Type
Active Comparator
Arm Description
Participants randomized to the ACB only group will receive an adductor canal block alone.
Arm Title
ACB + iPACK
Arm Type
Active Comparator
Arm Description
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Intervention Type
Drug
Intervention Name(s)
Adductor Canal Block (ACB) Only
Intervention Description
Patients will receive an ACB with lidocaine skin wheal
Intervention Type
Drug
Intervention Name(s)
Adductor Canal Block (ACB) + iPACK Block
Intervention Description
Patients will receive an ACB with iPACK block
Primary Outcome Measure Information:
Title
Pain Scores
Description
The primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome.
Time Frame
0-72 hours post op
Secondary Outcome Measure Information:
Title
total postoperative opioid consumption (total MME)
Description
The secondary endpoints will measure total perioperative opioid consumption through postoperative day 2
Time Frame
Post-Op Day 0-2
Title
Range of Motion (degrees)
Description
An additional secondary endpoint is the range of motion, measured in degrees, of the operative knee at post-op visit 1 and 2. The post-op measurements will be compared to the pre-operative measurements.
Time Frame
up to two months after surgery
Title
Terminal knee extension (degrees)
Description
The third secondary endpoint is the terminal knee extension, measured in degrees, of the operative knee at post-op visit 1 and 2. The post-op measurements will be compared to the pre-operative measurements.
Time Frame
up to two months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 12 years and older
Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.
Exclusion Criteria:
Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury.
Patients undergoing hamstring graft or allograft for ACL
Pre-existing infection at the site of injury
Patients on chronic opioid treatments
Pre-existing sensory or motor deficit in operative extremity
Patients having a revision of previous ACL reconstruction
Pregnant and/or lactating women
Weighs less than 40kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carey Breabaker, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
iPACK for Post-op Pain Following ACL Reconstruction
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