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Erector Spinae Plane Block for Uncomplicated Renal Colic

Primary Purpose

Renal Colic, Kidney Stone

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erector Spinae Plane Block (ESPB)
Ropivacaine
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Colic focused on measuring erector spinae plane block, Emergency Department, ropivacaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • The University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Erector Spinae Plane Block (ESPB)

External control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Rate of admission to hospital
Data for this outcome will be collected via electronic health record query.
Rate of 72-hour return to the Emergency Department (ED)
Data for this outcome will be collected via electronic health record query.

Full Information

First Posted
November 15, 2022
Last Updated
October 20, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05625802
Brief Title
Erector Spinae Plane Block for Uncomplicated Renal Colic
Official Title
Erector Spinae Plane Block for Uncomplicated Renal Colic
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic, Kidney Stone
Keywords
erector spinae plane block, Emergency Department, ropivacaine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block (ESPB)
Arm Type
Experimental
Arm Title
External control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block (ESPB)
Intervention Description
Up to 30 Cubic Centimeter (cc) of 0.5% ropivacaine administered by local injection into the erector spinae plane under ultrasound guidance
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
0.5% ropivacaine
Primary Outcome Measure Information:
Title
Proportion of patients receiving a second parenteral pain medication in the Emergency Department (ED)
Description
Data for this outcome will be collected via electronic health record query.
Time Frame
At ED discharge, approximately 1 day
Secondary Outcome Measure Information:
Title
Change in pain
Description
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.
Time Frame
Baseline, 60 minutes following procedure
Title
Rate of admission to hospital
Description
Data for this outcome will be collected via electronic health record query.
Time Frame
Up to 30-days
Title
Rate of 72-hour return to the Emergency Department (ED)
Description
Data for this outcome will be collected via electronic health record query.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Colmenero Mahmood
Phone
734-647-0574
Email
cico@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Fung
Phone
734-763-6370
Email
chfung@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Fung
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Colmenero Mahmood
Phone
734-647-0574
Email
cico@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Chris Fung

12. IPD Sharing Statement

Plan to Share IPD
No

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Erector Spinae Plane Block for Uncomplicated Renal Colic

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