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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Carmen Colmenero Mahmood; Phone Number: 734-647-0574; Email: cico@med.umich.edu
• Study Contact Backup: Name: Chris Fung; Phone Number: 734-763-6370; Email: chfung@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • The University of Michigan
      • Contact: Carmen Colmenero Mahmood; Phone Number: 734-647-0574; Email: cico@med.umich.edu
      • Principal Investigator: Chris Fung

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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients receiving a second parenteral pain medication in the Emergency Department (ED)	Data for this outcome will be collected via electronic health record query.	At ED discharge, approximately 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Pain ranked on a visual analog scale 1-10 where 10 indicates the most pain. Change is defined as the last pain score minus first pain score.	Baseline, 60 minutes following procedure
Rate of admission to hospital	Data for this outcome will be collected via electronic health record query.	Up to 30-days
Rate of 72-hour return to the Emergency Department (ED)	Data for this outcome will be collected via electronic health record query.	3 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 (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 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 (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Department; ropivacaine; erector spinae plane block
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Colic; Colic; Kidney Calculi; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; 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