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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 below
Select...
I am an adult scheduled for a kidney stone removal surgery on a weekday between 6 AM and 4 PM.

Timeline

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days for reporting.

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 more

Trial 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
5 Previous Clinical Trials
159 Total Patients Enrolled
Jason Buehler, MDPrincipal InvestigatorUniversity of Tennessee Medical Center

Media Library

ESP Group Clinical Trial Eligibility Overview. Trial Name: NCT05024344 — N/A
Kidney Stone Surgery Research Study Groups: ESP Group, Sham Group
Kidney Stone Surgery Clinical Trial 2023: ESP Group Highlights & Side Effects. Trial Name: NCT05024344 — N/A
ESP Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05024344 — N/A

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."

Answered by AI
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~26 spots leftby Dec 2024