iPACK for Post-op Pain Following ACL Reconstruction

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498870
• Other study ID #: Pro00121103
• Status: Completed
• Phase: Phase 4
• Start date: July 27, 2022
• Est. completion date: August 14, 2023

Study information

• Verified date: October 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 14, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Adductor Canal Block (ACB) Only
Patients will receive an ACB with lidocaine skin wheal
• Adductor Canal Block (ACB) + iPACK Block
Patients will receive an ACB with iPACK block

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	total postoperative opioid consumption (total MME)	The secondary endpoints will measure total perioperative opioid consumption through postoperative day 2	Post-Op Day 0-2
Secondary	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
Secondary	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