Actively Recruiting
The Effect of IPACK Nerve Blocks on Early ACL Pain Scores
Led by Loyola University · Updated on 2023-08-14
78
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether an anesthetic technique called the IPACK block can better control pain after anterior cruciate ligament (ACL) reconstruction surgery. This study aims to find out if patients receiving the IPACK block before surgery experience less pain immediately and one day after surgery, and if they need fewer opioids during the week following surgery. The trial is a double-blind, randomized study comparing the IPACK block to a placebo sham block. Participants will be randomly assigned to either the treatment group receiving the IPACK block or the control group receiving a placebo saline injection, both administered by the anesthesia team. The IPACK block involves injecting 20mL of 0.5% bupivacaine in a specific area near the knee, while the placebo group receives saline in the same manner. Both groups also receive standard care including an adductor canal block and skin infiltration with lidocaine. The study includes follow-up pain assessments immediately after surgery, at intervals up to 24 hours, and opioid usage tracking up to one week post-surgery. During the study, pain scores will be collected using a visual analogue scale in the recovery unit and during a follow-up phone call one day after surgery. Opioid consumption will be measured from hospital records starting at surgery until discharge, and from patient reports up to one week later. Researchers will compare pain levels and opioid use between groups to understand the impact of the IPACK block. Participation involves surgery with standard care, additional anesthesia procedures, and follow-up assessments over about one week.
CONDITIONS
Brief Title
IPACK on Early Pain Scores After ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients electing to undergo ACL reconstruction surgery with Dr. John Miller at Loyola University
- Patients aged 16 years or older
- English-speaking patients
- Patients able to make their own medical decisions and provide consent
You will not qualify if you...
- Previous surgery on the operative knee
- Previous knee infection
- Chronic opioid use
- Known allergy to local anesthetics
- Use of autograft (cadaver) for ACL reconstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants receive either the IPACK nerve block or a sham block during their ACL reconstruction surgery to manage postoperative pain.
1 in-person visit (surgery and immediate post-anesthesia care unit monitoring)
Duration - Up to 1 week after surgery
Participants have pain scores assessed immediately after surgery, 1 hour after waking, upon discharge, and during follow-up calls or visits up to one week after surgery to monitor pain and opioid use.
1 in-person post-operative visit and 2 follow-up phone calls
Trial Site Locations
Total: 1 location
1
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
Research Team
J
John Miller, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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