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ESPB for Kidney Stone Pain

Phase 2
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient received one dose of parenteral pain medication in the emergency department (ED)
Be older than 18 years old
Must not have
Prior spinal surgery in the thoracic region
Glucose-6-phosphate dehydrogenase deficiency (G6PD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 60 minutes following procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well a new spinal injection works to relieve kidney stone pain and if it has any side effects.

Who is the study for?
This trial is for adults with confirmed kidney stones who've had pain medication in the ER. It's not for pregnant or breastfeeding individuals, prisoners, those on blood thinners or with clotting issues, local anesthetic allergies, active COVID-19 infection, UTI treatments, prior thoracic spine surgery, skin infections at the injection site, strong CYP1A2 inhibitor users or G6PD deficiency.
What is being tested?
The study tests how effective the Erector Spinae Plane Block (ESPB) using Ropivacaine is in managing pain from kidney stones. ESPB is a type of regional anesthesia aimed at reducing discomfort.
What are the potential side effects?
Possible side effects include reactions to Ropivacaine such as numbness and tingling near the injection area, low blood pressure, nausea, vomiting and rarely more serious nerve damage or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I received an injection for pain in the emergency room.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery on my upper back.
Select...
I have G6PD deficiency.
Select...
I am currently on medication that strongly affects liver enzymes.
Select...
I have an infection on the skin where I would get the injection.
Select...
I am on blood thinners for a clotting disorder.
Select...
I am currently being treated for a urinary tract infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 60 minutes following procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 60 minutes following procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients receiving a second parenteral pain medication in the Emergency Department (ED)
Secondary study objectives
Change in pain
Rate of 72-hour return to the Emergency Department (ED)
Rate of admission to hospital

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Erector Spinae Plane Block (ESPB)Experimental Treatment2 Interventions
Group II: External controlActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erector Spinae Plane Block (ESPB)
2023
N/A
~110
Ropivacaine
2017
Completed Phase 4
~1960

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,855 Previous Clinical Trials
6,435,001 Total Patients Enrolled
Chris FungStudy ChairUniversity of Michigan

Media Library

Erector Spinae Plane Block (ESPB) Clinical Trial Eligibility Overview. Trial Name: NCT05625802 — Phase 2
Ureteral Colic Research Study Groups: Erector Spinae Plane Block (ESPB), External control
Ureteral Colic Clinical Trial 2023: Erector Spinae Plane Block (ESPB) Highlights & Side Effects. Trial Name: NCT05625802 — Phase 2
Erector Spinae Plane Block (ESPB) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625802 — Phase 2
~13 spots leftby Jun 2025
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