Your session is about to expire
← Back to Search
IPACK Block for Postoperative Pain After ACL Surgery
Phase 4
Recruiting
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English speaking patients
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 hours after surgery; 1 week after surgery
Awards & highlights
Study Summary
This trial tests whether an anesthetic technique called IPACK block can help reduce pain and opioid use after ACL surgery. Participants will be randomly assigned to either receive IPACK or placebo. Pain scores and opioid use will be compared.
Who is the study for?
This trial is for patients 16 or older who are undergoing ACL reconstruction at Loyola University Medical Center and can make their own medical decisions. It's not for those with chronic opioid use, using cadaver grafts, allergic to local anesthetics, or with past surgery/infections in the knee.Check my eligibility
What is being tested?
The study tests if the IPACK block—anesthetic technique—reduces pain and opioid use after ACL surgery compared to a placebo. Participants are randomly assigned to either receive IPACK or a placebo without knowing which one they get.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally local anesthetics like those used in IPACK blocks may cause reactions at the injection site, numbness beyond the target area, headaches, or low blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English.
Select...
I am choosing to have ACL surgery with Dr. John Miller at Loyola University.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-3 hours after surgery; 1 week after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 hours after surgery; 1 week after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid Consumption
Pain Scores
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IPACKExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IPACK
2020
N/A
~90
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,856 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 16 years old or older.I speak English.I can make my own medical decisions and agree to join the study.I am using a cadaver's tissue for my ACL surgery.I am choosing to have ACL surgery with Dr. John Miller at Loyola University.I have had a knee infection before.I have had surgery on my knee before.You have been using opioid pain medications for a long time.You are allergic to local anesthetics.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: IPACK
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does IPACK pose any notable health risks for individuals?
"After conducting a risk assessment, our team at Power rated the safety of IPACK to be 3 due to this being an approved Phase 4 trial."
Answered by AI
Are there any opportunities for participant enrollment in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research endeavour is currently recruiting participants for involvement; it was first posted on August 3rd 2023 and its most recent alteration occurred the same day. 78 people from 1 particular location are needed to complete the trial."
Answered by AI
How many enrollees are currently in this research endeavor?
"Indeed, the information published on clinicaltrials.gov affirms that this medical trial is currently recruiting participants. This initiative was first posted on August 3rd 2023 and has since been updated to reflect its most recent status. A total of 78 patients need to be registered from a single location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger