Recruiting

IPACK

Sponsor:

Loyola University

Code:

NCT05985629

Conditions

Pain, Postoperative

Anterior Cruciate Ligament Injuries

Analgesics, Opioid

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

IPACK

PLACEBO

Study Details

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

Study ID

NCT05985629

Start date

Aug 3, 2023

Status verified date

Aug, 2023

Completion date

Aug 3, 2026

Anticipated

Primary completion date

Aug 3, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IPACK

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.

placebo comparator: Placebo

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.

Interventions

IPACK

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.

PLACEBO

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.

Primary outcome measure

  • Pain Scores [ Time Frame: Immediately after surgery; 1 hour, 2-3 hours, and 24 hours after surgery ]
  • Opioid Consumption [ Time Frame: 2-3 hours after surgery; 1 week after surgery ]

Central Contacts and Locations

Central contacts

John Miller, MD

708-216-8730johnmiller@lumc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Susan Fargo, BA, CIP, CCRP

708-216-8046sfargo@luc.edu

Principal Investigator:

John Miller, MD

More Information

Sponsor

Loyola University

Last update posted

Aug 14, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2023-08-14.