- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05323175
Erector Spinae Plane (ESP) Block for Renal Colic
June 1, 2026 updated by: Michael Secko, MD, Stony Brook University
Can Erector Spinae Plane (ESP) Block Better Relieve Acute Renal Colic Pain Than Standard of Care
Comparing standard of care to erector spinae plane block for acute renal colic pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Will compare at times 0, 10 minute, 20 minute, 40 minute and 60 minutes after local nerve block given.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- StonyBrook University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 to 65 years old
- ASA Level I and II
- flank pain concerning for renal colic in ED
Exclusion Criteria:
- pregnant women
- subjects unable to appreciate ESP block landmarks under ultrasound
- skin infection over needle site insertion
- Allergy to local anesthesia (lidocaine/Ropivacaine)
- bleeding disorders
- serious cardiac, lung, liver or kidney dysfunction
- history of spine surgery
- history of spinal infection
- history of epidural injection within 6 months
- acute exacerbation of serious mental disease
- unable to consent
- unable to communicate pain level
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ESP Nerve Block for Renal colic
On top of receiving standard of care, At T8 nerve level, with ultrasound guidance to bathe the nerve
|
Local anesthesia injected under ultrasound guidance
|
|
Active Comparator: Standard of care
Whatever medications the clinician normally treats renal colic with
|
Whatever the ED clinicians normally give for renal colic pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline Pain before intervention
Time Frame: Before the ESP Block
|
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
|
Before the ESP Block
|
|
Pain score at 10 minutes
Time Frame: 10 minutes after the ESP Block
|
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
|
10 minutes after the ESP Block
|
|
Pain score at 20 minutes
Time Frame: 20 minutes after ESP Block
|
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
|
20 minutes after ESP Block
|
|
Pain score at 40 minutes
Time Frame: 40 minutes after ESP Block
|
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
|
40 minutes after ESP Block
|
|
Pain score at 60 minutes
Time Frame: 60 minutes after ESP Block
|
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
|
60 minutes after ESP Block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for extra opiates
Time Frame: Starting from time 0 after the ESP Block intervention completed till discharge or urology intervention
|
Record how much opioids patients receives starting after the ESP Block for both the "standard of care" patients and the ESP Block group
|
Starting from time 0 after the ESP Block intervention completed till discharge or urology intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Secko, MD, StonyBrook University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2022
Primary Completion (Actual)
January 9, 2026
Study Completion (Actual)
January 9, 2026
Study Registration Dates
First Submitted
October 8, 2021
First Submitted That Met QC Criteria
April 11, 2022
First Posted (Actual)
April 12, 2022
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2021-00518
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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