iPACK for Post-op Pain Following ACL Reconstruction

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

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain; ACL Injury
• Intervention / Treatment: Drug: Adductor Canal Block (ACB) Only; Drug: Adductor Canal Block (ACB) + iPACK Block

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Carey Breabaker, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Actual): July 3, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: acl injury; acl repair
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Knee Injuries; Pain, Postoperative; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: Pro00121103

Drug and device information, study documents

• 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