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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
Must not have
Emergent surgery status
History of Guillain-Barre' Syndrome
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
Awards & highlights
Approved for 60 Other Conditions
All Individual Drugs Already Approved

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I require immediate surgery.
Select...
I have had Guillain-Barre Syndrome in the past.
Select...
I have an infection at a specific site.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Opioid consumption (MME)
Secondary study objectives
Hospital LOS
Opioid use during 30 days post hospital discharge
Opioid use during first 24 hours after surgery
+2 more

Awards & Highlights

Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
~3 spots leftby Dec 2024