Erector Spinae Plane Block for Uncomplicated Renal Colic

Erector Spinae Plane Block for Uncomplicated Renal Colic

Sponsors

Lead Sponsor: University of Michigan

Source 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.

Overall Status Recruiting
Start Date 2022-11-01
Completion Date 2023-11-01
Primary Completion Date 2023-10-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of patients receiving a second parenteral pain medication in the Emergency Department (ED) At ED discharge, approximately 1 day
Secondary Outcome
Measure Time Frame
Change in pain Baseline, 60 minutes following procedure
Rate of admission to hospital Up to 30-days
Rate of 72-hour return to the Emergency Department (ED) 3 days
Enrollment 60
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Erector Spinae Plane Block (ESPB)

Description: Up to 30 Cubic Centimeter (cc) of 0.5% ropivacaine administered by local injection into the erector spinae plane under ultrasound guidance

Arm Group Label: Erector Spinae Plane Block (ESPB)

Intervention Type: Drug

Intervention Name: Ropivacaine

Description: 0.5% ropivacaine

Arm Group Label: Erector Spinae Plane Block (ESPB)

Eligibility

Criteria:

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Chris Fung Study Chair University of Michigan
Overall Contact

Last Name: Carmen Colmenero Mahmood

Phone: 734-647-0574

Email: [email protected]

Location
Facility: Status: Contact: Investigator: The University of Michigan Carmen Colmenero Mahmood 734-647-0574 [email protected] Chris Fung Principal Investigator
Location Countries

United States

Verification Date

2022-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Michigan

Investigator Full Name: Christopher Fung

Investigator Title: Assistant Professor in Emergency Medicine - Adult

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Erector Spinae Plane Block (ESPB)

Type: Experimental

Label: External control

Type: No Intervention

Patient Data No
Study Design Info

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 arm

Primary Purpose: Supportive Care

Masking: None (Open Label)

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