Erector Spinae Plane Block for Uncomplicated Renal Colic

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

Official Title
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Erector Spinae Plane Block for Uncomplicated Renal Colic

Conditions
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Renal Colic, Kidney Stone

Intervention / Treatment
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* Procedure: Erector Spinae Plane Block (ESPB)
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single site two-stage open label phase 2 clinical trial with one treatment arm and one external control arm
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spinae plane block, Emergency Department, ropivacaine