Erector Spinae Plane Block for Uncomplicated Renal Colic

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05625802

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Colic Kidney Stone	Procedure: Erector Spinae Plane Block (ESPB) Drug: Ropivacaine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single site two-stage open label phase 2 clinical trial with one treatment arm and one external control armSingle site two-stage open label phase 2 clinical trial with one treatment arm and one external control arm

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Erector Spinae Plane Block for Uncomplicated Renal Colic

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)