IPACK on Early Pain Scores After ACL Reconstruction

NCT05985629 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: LU 216180
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether using an anesthetic technique called IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to answer are:

• if participants who receive the IPACK block prior to ACL reconstruction experience less pain after surgery and at 1 day after surgery
• if participants who receive the IPACK block prior to ACL reconstruction require less short-term opioid use immediately after surgery and up to one week after surgery. Participants will be randomized 1:1 to 1 of 2 groups: Use of IPACK block during ACL reconstruction vs. placebo (a placebo is a look-alike substance that contains no active drug). Neither the participant nor the investigator will know which group the participants has been assigned to. Researchers will compare self-reported pain scores and short-term opioid use of all study participants.

Conditions

Pain, Postoperative; Anterior Cruciate Ligament Injuries; Analgesics, Opioid

Outcome Measures

Primary Outcomes (2)

• Pain Scores

  Visual Analogue Scale (VAS). Participants self-report their post surgical pain from a scale of 0 to 10.

  Immediately after surgery; 1 hour, 2-3 hours, and 24 hours after surgery

• Opioid Consumption

  Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery.

  2-3 hours after surgery; 1 week after surgery

Study Arms (2)

IPACK

EXPERIMENTAL

After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of 0.5% bupivacaine will be injected.

Drug: IPACK

Placebo

PLACEBO COMPARATOR

After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of normal saline will be injected.

Drug: PLACEBO

Interventions

IPACK DRUG

Infiltration between the popliteal artery and capsules of the knee (IPACK) is a novel ultrasound-guided technique that provides additional regional analgesic relief to the posterior aspect of the knee without complications seen in a sciatic nerve block. The intention of the IPACK block is to anesthetize the terminal sensory nerves while sparing the main trucks of the common peroneal and tibial nerves.

IPACK

PLACEBO DRUG

The control group will receive the normal pre-procedure care including a pre-operative visit, surgery, and post-operative care. The control group will receive a sham block consisting of saline in the same anatomical location and manner that the intervention IPACK block is administered.

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting to Dr. John Miller with the Department of Orthopedic Surgery, Sports Medicine Division, at Loyola University Medical Center electing to undergo ACL reconstruction surgery.
• Patients 16 and over
• English speaking patients
• Patients who have the capacity to make their own medical decisions and consent to the study

You may not qualify if:

• Previous surgery on the operative knee
• Previous knee infection
• Chronic opioid use
• Have a known allergy to local anesthetics
• Patient using autograft (cadaver) for ACL reconstruction.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

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

Central Study Contacts

John Miller, MD

CONTACT

708-216-8730; johnmiller@lumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: An unblinded pharmacist will prepare the study drugs consisting of IPACK block, or the sham block consisting of saline (control group). All patients will be premedicated with midazolam, which is standard of care prior to general anesthesia. The use of a sham block, administered by the anesthesia team, is to ensure that the Investigator is blinded to patient's treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 3, 2023
• Primary Completion: August 3, 2025
• Study Completion (Estimated): August 3, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (1)