Erector Spinae Plane Block for Uncomplicated Renal Colic

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

Study Overview

• Status: Completed
• Conditions: Renal Colic; Kidney Stone
• Intervention / Treatment: Procedure: Erector Spinae Plane Block (ESPB); Drug: Ropivacaine

Detailed Description

When this trial was initially started, the intent was to compare the Erector Spinae Plane Block (ESPB) arm to data from electronic health records (EHR) of patients who had not received the ESPB. The EHR data was never obtained, so no comparison was conducted.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector Spinae Plane Block (ESPB); 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); Up to 30 Cubic Centimeter (cc) of 0.5% ropivacaine administered by local injection into the erector spinae plane under ultrasound guidance; Drug: Ropivacaine; 0.5% ropivacaine
No Intervention: External control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Pain ranked on a visual analog scale of 1-10, where 10 indicated the most pain and 1 indicated no pain. Change was defined as the last pain score minus first pain score.	Baseline, 5 minutes, and 60 minutes following procedure
Rate of Admission to Hospital for Kidney Stones	Results reflect participants who were admitted to the hospital for kidney stones at or prior to day 7 and at or prior to day 30 following administration of the intervention. Data for this outcome was collected via electronic health record query.	Up to 30 days
Rate of 24-hour and 72-hour Return to the Emergency Department (ED)	Results reflect participants who returned to the ED for kidney stone-related issues at 24 hours and 72 hours following administration of the intervention. Data for this outcome was collected via electronic health record query.	Up to 72 hours
Emergency Department Length of Stay	Average length of stay in the emergency department per participant.	Up to 30 days
Safety Outcomes and Complications	Results reflect the number of participants who were still in the trial by day 30 and had experienced any of the pre-defined safety events.	Up to 30 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Study Chair: Chris Fung, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Actual): January 3, 2024
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Emergency Department; ropivacaine; erector spinae plane block
• Additional Relevant MeSH Terms: Urogenital Diseases; Pain; Neurologic Manifestations; Pathologic Processes; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Disease Attributes; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Kidney Calculi; Emergencies; Renal Colic; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine
• Other Study ID Numbers: HUM00219913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes