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Procedure
Combined Nerve Blocks for Postoperative Knee Surgery Pain
N/A
Recruiting
Led By Roya Yumul, M.D.,PhD.
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-90 yrs
The American Society of Anesthesiologists (ASA) Physical Status 1-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op day 1,2,3
Awards & highlights
Study Summary
This trial is testing whether adding two different types of nerve blocks to a traditional nerve block used for pain relief after knee surgery provides better pain relief, decreases pain scores, and decreases the need for opioids while also helping patients recover more quickly.
Who is the study for?
This trial is for men and women aged 18-90, in stable physical condition (ASA status 1-3), undergoing knee replacement surgery. It's not for those who refuse to participate, are under general anesthesia, have bilateral or revised knee surgeries, or have conditions that make nerve blocks risky like infections at the needle site or bleeding disorders.Check my eligibility
What is being tested?
The study tests if adding an anterior femoral block (AFB) and/or a genicular block (iPACK) to the adductor canal block (ACB) can better manage pain after knee surgery. The goal is to see if these combinations lower pain scores, reduce opioid use, speed up recovery, and improve patient satisfaction with pain control.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, possible infection risk from needles used for nerve blocks, temporary numbness or weakness in the leg due to nerve blockade which could affect mobility post-surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 90 years old.
Select...
My overall health is good to moderately impaired.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-op day 1,2,3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-op day 1,2,3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes of pain scores (VRS) at motion activity
Changes of pain scores (VRS) at rest
Secondary outcome measures
Gait distance
Patient satisfaction score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Adductor canal ACB + genicular (IPACK)Experimental Treatment1 Intervention
Group II Adductor canal block (ACB): 0.25% bupivacaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with 0.25% Bupivicaine with 1:200,000 epinephrine 15 ml
Group II: Adductor canal block (ACB)Active Control1 Intervention
Group I Adductor canal block (ACB): 0.25% bupivacaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with normal saline 15 ml
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,719 Total Patients Enrolled
1 Trials studying Postoperative Pain
127 Patients Enrolled for Postoperative Pain
Roya Yumul, M.D.,PhD.Principal Investigator - Department of Anesthesiology
Cedars-Sinai Medical Center, General Anesthesia Specialists Partnership Medical Group
University Hamburg (Medical School)
Chas R Drew University Medical & Sci (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 90 years old.I do not want to participate in the study.I will undergo surgery with general anesthesia.I have had both knees replaced or one knee replacement revised.I cannot have a regional block due to an infection, bleeding disorder, or personal choice.My gender does not affect my eligibility.I am between 18 and 90 years old.My overall health is good to moderately impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Adductor canal block (ACB)
- Group 2: Adductor canal ACB + genicular (IPACK)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is the age criterion for inclusion in this trial more than twenty years of age?
"The age range for participants in this trial is from 18 years and up to 90 years."
Answered by AI
Do I meet the prerequisites to join this experiment?
"This clinical trial is seeking to recruit 144 individuals who are suffering from postoperative pain and lie between 18-90 years of age."
Answered by AI
How many individuals have been chosen to participate in this research endeavor?
"Affirmative, the record on clinicaltrials.gov affirms that this investigation is presently enrolling participants. It was originally posted on October 1st 2017 and most recently revised on August 28th 2023. A total of 144 subjects are required from a single site for completion of the trial."
Answered by AI
Are there any available openings for participation in this research endeavor?
"Affirmative. The clinicaltrials.gov website mentions that this trial has recently begun recruiting patients, first posted on October 1st 2017 and updated as of August 28th 2023. This medical study needs to locate 144 volunteers from a single site."
Answered by AI
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