Recruiting

ESP Block vs. Control

Sponsor:

University of Tennessee Medical Center

Code:

NCT05024344

Conditions

Nephrolithotomy, Percutaneous

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Erector Spinae Plane Block

Ropivacaine 0.5% Injectable Solution

Dexamethasone

Study Details

Brief summary:

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.

Conditions

Nephrolithotomy, Percutaneous

Study ID

NCT05024344

Start date

Aug 9, 2021

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: ESP Group

One 30mL syringe containing 30mL of 0.5% ropivacaine and 4 mg of dexamethosone-

sham comparator: Sham Group

One 30mL syringe containing 30mL of preservative free normal saline

Interventions

Erector Spinae Plane Block

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

Ropivacaine 0.5% Injectable Solution

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

Dexamethasone

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

Primary outcome measure

  • Opioid consumption (MME) [ Time Frame: First 24 hours postoperative ]

Central Contacts and Locations

Central contacts

Jason Buehler, MD

865-305-9220jbuehler@utmck.edu

Aimee Pehrson

865-305-5432apehrson@utmck.edu

Locations

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Aimee Pehrson

865-305-5432apehrson@utmck.edu

More Information

Sponsor

University of Tennessee Medical Center

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Medical Center on 2026-04-28.