Erector Spinae Plane Block for Uncomplicated Renal Colic

Phase 2

Recruiting

• Conditions: Renal Colic; Kidney Stone
• Interventions: Procedure: Erector Spinae Plane Block (ESPB); Drug: Ropivacaine

• Registration Number: NCT05625802
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-11-23
• Study Start: 2023-02-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-06
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block (ESPB)	Ropivacaine	-
Erector Spinae Plane Block (ESPB)	Erector Spinae Plane Block (ESPB)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in pain	Baseline, 60 minutes following procedure	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.
Rate of admission to hospital	Up to 30-days	Data for this outcome will be collected via electronic health record query.
Rate of 72-hour return to the Emergency Department (ED)	3 days	Data for this outcome will be collected via electronic health record query.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States