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ESP Block for Pain After Kidney Stone Surgery
N/A
Recruiting
Led By Jason Buehler, MD
Research Sponsored by University of Tennessee Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults, male and female greater than or equal to 18 years of age and undergoing non-emergent percutaneous nephrolithotomy Monday through Friday between the hours of 6:00AM and 4:00PM
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours, 48 hours, 7 days, and 30 days after surgery
Awards & highlights
Study Summary
This trial is investigating whether or not a certain type of nerve block can help reduce pain and the amount of pain medication needed after a surgery to remove kidney stones.
Who is the study for?
This trial is for English-speaking adults over 18 who are having non-emergency kidney stone surgery (percutaneous nephrolithotomy) during weekdays. They must be able to understand and explain the consent process, and women of childbearing age need a negative pregnancy test.Check my eligibility
What is being tested?
The study tests if an ESP block with Ropivacaine and Dexamethasone reduces painkiller needs after kidney stone surgery compared to a saline solution control. It also looks at its effect on reported pain levels post-surgery.See study design
What are the potential side effects?
Possible side effects may include discomfort or pain at the injection site, allergic reactions to medications used in the ESP block, nerve damage, low blood pressure, or changes in heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult scheduled for a kidney stone removal surgery on a weekday between 6 AM and 4 PM.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid consumption (MME)
Secondary outcome measures
Hospital LOS
Opioid use during 30 days post hospital discharge
Opioid use during first 24 hours after surgery
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: ESP GroupActive Control3 Interventions
One 30mL syringe containing 30mL of 0.5% ropivacaine and 4 mg of dexamethosone-
Group II: Sham GroupPlacebo Group1 Intervention
One 30mL syringe containing 30mL of preservative free normal saline
Find a Location
Who is running the clinical trial?
University of Tennessee Medical CenterLead Sponsor
4 Previous Clinical Trials
129 Total Patients Enrolled
Jason Buehler, MDPrincipal InvestigatorUniversity of Tennessee Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that would make the trial unsafe for me.I require immediate surgery.I have had Guillain-Barre Syndrome in the past.I can have children and will provide a negative pregnancy test.I am an adult scheduled for a kidney stone removal surgery on a weekday between 6 AM and 4 PM.I have an infection at a specific site.
Research Study Groups:
This trial has the following groups:- Group 1: ESP Group
- Group 2: Sham Group
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
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.
How is ESP Group used to help patients?
"ESP Group is an ophthalmic drug that is used to manage sympathetic ophthalmia. It is also effective in treating branch retinal vein occlusion, macular edema, and certain communicable diseases."
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