iPACK for Post-op Pain Following ACL Reconstruction

NCT05498870 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00121103
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury; Post Operative Pain

Keywords

acl injury; acl repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total Postoperative Opioid Consumption (Total MME)

  up to 72 hours post-op

• Range of Motion (Degrees)

  up to two months after surgery

Study Arms (2)

Adductor Canal Block (ACB) Only

ACTIVE COMPARATOR

Participants randomized to the ACB only group will receive an adductor canal block alone.

Drug: Adductor Canal Block (ACB) Only

ACB + iPACK

ACTIVE COMPARATOR

Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.

Drug: Adductor Canal Block (ACB) + iPACK Block

Interventions

Adductor Canal Block (ACB) Only DRUG

Patients will receive an ACB with lidocaine skin wheal

Adductor Canal Block (ACB) Only

Adductor Canal Block (ACB) + iPACK Block DRUG

Patients will receive an ACB with iPACK block

ACB + iPACK

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 12 years and older
• Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Pain, Postoperative

Interventions

Single Person

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Results Point of Contact

• Title: Carey Brewbaker
• Organization: Medical University of South Carolina

brewbake@musc.edu

843-792-2322

Study Officials

• Carey Breabaker, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the patient will be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 12, 2022
• Study Start: August 25, 2022
• Primary Completion: July 3, 2023
• Study Completion: August 14, 2023
• Last Updated: October 16, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-10

Locations

US (1)