Erector Spinae Plane Block for Uncomplicated Renal Colic

NCT05625802 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HUM00219913
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is to determine how well the Erector Spinae Plane Block (ESPB) works for kidney stone pain and any possible side effects.

Conditions

Renal Colic; Kidney Stone

Keywords

erector spinae plane block; Emergency Department; ropivacaine

Outcome Measures

Primary Outcomes (1)

• Participants Who Received a Second Parenteral Pain Medication in the Emergency Department (ED)

  Results reflect the number of participants who received a second parenteral pain medication after receiving one already. Data for this outcome was collected via electronic health record query.

  By ED discharge, approximately 12 hours or less

Secondary Outcomes (5)

• Change in Pain

  Baseline, 5 minutes, and 60 minutes following procedure

• Rate of Admission to Hospital for Kidney Stones

  Up to 30 days

• Rate of 24-hour and 72-hour Return to the Emergency Department (ED)

  Up to 72 hours

• Emergency Department Length of Stay

  Up to 30 days

• Safety Outcomes and Complications

  Up to 30 days

Study Arms (2)

Erector Spinae Plane Block (ESPB)

EXPERIMENTAL

Intervention inhibits neurotransmission at the dorsal and ventral rami of the thoracic spinal nerves, providing anesthesia to multiple dermatomal levels

Procedure: Erector Spinae Plane Block (ESPB); Drug: Ropivacaine

External control

NO INTERVENTION

External control patients will be selected from a population of patients meeting the following criteria: 1) adult ED patient with the diagnosis of uncomplicated kidney stones; 2) received at least one dose of parenteral medication while in the ED; 3) presentation to the ED between 7/1/2021 and the study start date. From this population, propensity score matched control patients will be selected at a ratio of 3 controls to 1 ESPB patient. External control population patients are not active patients in this study and analysis of their data will be secondary use of data collected during routine care.

Interventions

Erector Spinae Plane Block (ESPB) PROCEDURE

Up to 30 Cubic Centimeter (cc) of 0.5% ropivacaine administered by local injection into the erector spinae plane under ultrasound guidance

Erector Spinae Plane Block (ESPB)

Ropivacaine DRUG

0.5% ropivacaine

Erector Spinae Plane Block (ESPB)

Eligibility Criteria

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

You may qualify if:

• Imaging confirmation of urolithiasis on the index encounter or prior encounter within 7 days
• Patient received one dose of parenteral pain medication in the emergency department (ED)

You may not qualify if:

• Pregnancy or breastfeeding
• Prisoner or incarcerated individual
• Therapeutic anticoagulation or coagulopathy.
• Active treatment for urinary tract infection (either acute infection or chronic therapy)
• Prior spinal surgery in the thoracic region
• Allergy to local anesthetic or prior local anesthetic
• Soft tissue infection overlying the injection site
• Positive for coronavirus
• Inability to communicate verbally or read/write in English
• Currently taking strong CYP1A2 inhibitor (fluvoxamine, amiodarone, fluoroquinolones, etc.)
• Glucose-6-phosphate dehydrogenase deficiency (G6PD)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Renal Colic; Kidney Calculi; Emergencies

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Christopher Fung
• Organization: University of Michigan

chfung@med.umich.edu

734-763-4091

Study Officials

• Chris Fung

  University of Michigan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Emergency Medicine - Adult

Model Details: Single site two-stage open label phase 2 clinical trial with one treatment arm and one external control arm

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: February 8, 2023
• Primary Completion: January 3, 2024
• Study Completion: February 2, 2024
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)