iPACK for Post-op Pain Following ACL Reconstruction

Study Overview
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Brief Summary
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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.

Official Title
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Studying the Effects of iPACK Blocks With Adductor Canal Blocks for Postoperative Analgesia Following ACL Reconstruction

Conditions
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ACL Injury, Post Operative Pain

Intervention / Treatment
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* Drug: Adductor Canal Block (ACB) Only
* Drug: Adductor Canal Block (ACB) + iPACK Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adductor Canal Block (ACB) Only<br>Participants randomized to the ACB only group will receive an adductor canal block alone. | Drug: Adductor Canal Block (ACB) Only<br>* Patients will receive an ACB with lidocaine skin wheal<br>|
| Active Comparator: ACB + iPACK<br>Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block. | Drug: Adductor Canal Block (ACB) + iPACK Block<br>* Patients will receive an ACB with iPACK block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-72 hours post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total postoperative opioid consumption (total MME) | The secondary endpoints will measure total perioperative opioid consumption through postoperative day 2 | Post-Op Day 0-2 | 
| 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. | up to two months after surgery | 
| 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. | up to two months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acl injury, acl repair