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NCT Number: NCT05985629

IPACK on Early Pain Scores After ACL Reconstruction

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.

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Key information

Conditions

Pain, Postoperative Analgesics, Opioid Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location status: Recruiting

Location contact

John Miller, MD

PRINCIPAL_INVESTIGATOR

Scott Byram, MD

SUB_INVESTIGATOR

Susan Fargo, BA, CIP, CCRP

CONTACT

[email protected]

708-216-8046

About this study

Eligible patients will be approached for voluntary study participation after they have made the decision to pursue an elective ACL reconstruction surgery with Dr. John Miller of Loyola University Department of Orthopedic Surgery for management of their ACL tear.

The study design is a double-blind, randomized trial. Patients will be randomly selected to the control group or the treatment group. The groups will be randomized 1:1 using a block method to be implemented. The control group will receive a sham block, while the treatment group will receive the IPACK block. The use of a sham block, administered by the anesthesia team, is to ensure that Dr. Miller is blinded to patient's treatment group. After administration of the block and a completed ACL reconstruction surgery, pain scores will be collected from the patient at two time points. First, pain scores will be collected in the post-anesthesia care (PACU) unit using the visual analogue scale (VAS) immediately upon waking up, one hour after waking up and upon discharge. Second, pain scores will be collected during the standard post-operative follow-up phone call that Dr. Miller makes with all his patients one day after surgery using the VAS pain scale. 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 using a simple questionnaire

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Scores

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

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

  2. Opioid Consumption

    Time frame: 2-3 hours after surgery; 1 week after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

John Miller, MD

CONTACT

[email protected]

708-216-8730

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

The Effect of IPACK Nerve Blocks on Early ACL Pain Scores

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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