Actively Recruiting

Phase 4
Age: 16Years +
All Genders
ID05985629

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

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-operative Follow-up

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

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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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