ESP Block vs Control for Pain Control Following Percutaneous Nephrolithotomy

NCT05024344 | Recruiting

• 1 other identifier: ANES-01-072021
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Opioid consumption (MME)

  Opioid consumption (MME) in the first 24 hours postoperative

  First 24 hours postoperative

Secondary Outcomes (5)

• Hospital LOS

  Number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days

• VAS score

  First 24 hours after surgery.

• Opioid use during first 24 hours after surgery

  24 hours

• QoR-15

  24 hours, 48 hours, 7 days, and 30 days after surgery

• Opioid use during 30 days post hospital discharge

  30 days

Study Arms (2)

ESP Group

ACTIVE COMPARATOR

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

Procedure: Erector Spinae Plane Block; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Dexamethasone

Sham Group

SHAM COMPARATOR

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

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

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

ESP Group; Sham Group

Ropivacaine 0.5% Injectable Solution DRUG

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

ESP Group

Dexamethasone DRUG

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

ESP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• University of Tennessee Medical Center: lead

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

Related Publications (8)

• Dundar G, Gokcen K, Gokce G, Gultekin EY. The Effect of Local Anesthetic Agent Infiltration Around Nephrostomy Tract On Postoperative Pain Control After Percutaneous Nephrolithotomy: A single-centre, randomised, double-blind, placebocontrolled clinical trial. Urol J. 2018 Nov 17;15(6):306-312. doi: 10.22037/uj.v0i0.4145.

  PMID: 29681047 BACKGROUND

• De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.

  PMID: 30621377 BACKGROUND

• Tulgar S, Selvi O, Ozer Z. Clinical experience of ultrasound-guided single and bi-level erector spinae plane block for postoperative analgesia in patients undergoing thoracotomy. J Clin Anesth. 2018 Nov;50:22-23. doi: 10.1016/j.jclinane.2018.06.034. Epub 2018 Jun 23. No abstract available.

  PMID: 29940470 BACKGROUND

• Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. No abstract available.

  PMID: 31044575 BACKGROUND

• Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.

  PMID: 31620856 BACKGROUND

• Govender S, Mohr D, Van Schoor AN, Bosenberg A. The extent of cranio-caudal spread within the erector spinae fascial plane space using computed tomography scanning in a neonatal cadaver. Paediatr Anaesth. 2020 Jun;30(6):667-670. doi: 10.1111/pan.13864. Epub 2020 Apr 22.

  PMID: 32267041 BACKGROUND

• Ugras MY, Toprak HI, Gunen H, Yucel A, Gunes A. Instillation of skin, nephrostomy tract, and renal puncture site with ropivacaine decreases pain and improves ventilatory function after percutaneous nephrolithotomy. J Endourol. 2007 May;21(5):499-503. doi: 10.1089/end.2006.0335.

  PMID: 17523902 BACKGROUND

• Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.

  PMID: 30292068 RESULT

MeSH Terms

Interventions

Ropivacaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jason Buehler, MD

  University of Tennessee Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Buehler, MD

CONTACT

865-305-9220; jbuehler@utmck.edu

Aimee Pehrson

CONTACT

865-305-5432; apehrson@utmck.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 27, 2021
• Study Start: August 9, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)