What this study is
The purpose of this study is to investigate the use of the erector spinae (ESP) block in reducing the morphine milligram equivalent (MME) consumption post percutaneous nephrolithotomy. Objectives:
1. - Determine if there is a significant effect on post percutaneous nephrolithotomy MME consumption with the usage of an ESP block vs. saline control. 2. - Determine if there is a significant effect on reported pain levels with the use of an ESP block vs. saline control in post percutaneous nephrolithotomies.
What's being tested
- Erector Spinae Plane Block
Intervention · PROCEDURE
- Ropivacaine 0.5% Injectable Solution
Intervention · DRUG
- Dexamethasone
Intervention · DRUG
All interventions
The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
Study details
- Official title
- Erector Spinae Plane Block Versus Control for Pain Control Following Percutaneous Nephrolithotomy: A Randomized, Double-Blind, Placebo Controlled Study
- Sponsor
- University of Tennessee Medical Center
- Conditions
- Nephrolithotomy, Percutaneous
- Enrolling
- 128 people
- Starts
- 2021-08-09
- Est. completion
- 2028-06-30
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
- Female participants of childbearing potential will be required to provide a negative pregnancy test.
- Ability to understand and teach back consent for the procedure.
- Willingness to sign consent for procedure.
- English speaking.
You can't join if
- Emergent surgery status.
- Local infection
- Allergy to local anesthetics.
- Recreational drug use.
- Inability to provide informed consent.
- Pregnancy or breastfeeding.
- History of Guillain-Barre' Syndrome.
- Underlying medical conditions that would post a significant risk to the patient.
- Opioid use >90 days in the year leading up to surgery.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Tennessee Medical Center
Knoxville, Tennessee, United States
- Aimee Pehrson · Contact865-305-5432apehrson@utmck.edu
Recruiting
Study team
Sponsor
University of Tennessee Medical Center
Study ID ANES-01-072021
Principal investigator
Jason Buehler, MD
University of Tennessee Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.