Back to resultsErector Spinae Plane (ESP) Block for Renal Colic
Primary Purpose
Renal Colic
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine injection
Standard of care medications
Sponsored by
About this trial
This is an interventional other trial for Renal Colic focused on measuring Erector spinae plane block
Eligibility Criteria
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
Sites / Locations
- StonyBrook University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ESP Nerve Block for Renal colic
Standard of care
Arm Description
On top of receiving standard of care, At T8 nerve level, with ultrasound guidance to bathe the nerve
Whatever medications the clinician normally treats renal colic with
Outcomes
Primary Outcome Measures
Baseline Pain before intervention
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Pain score at 10 minutes
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Pain score at 20 minutes
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Pain score at 40 minutes
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
Pain score at 60 minutes
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
Secondary Outcome Measures
Need for extra opiates
Record how much opioids patients receives starting after the ESP Block for both the "standard of care" patients and the ESP Block group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05323175
Brief Title
Erector Spinae Plane (ESP) Block for Renal Colic
Official Title
Can Erector Spinae Plane (ESP) Block Better Relieve Acute Renal Colic Pain Than Standard of Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparing standard of care to erector spinae plane block for acute renal colic pain.
Detailed Description
Will compare at times 0, 10 minute, 20 minute, 40 minute and 60 minutes after local nerve block given.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
Erector spinae plane block
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Standard of care group + sham normal saline ESP block vs Standard of care + Ropivacaine ESP nerve Block group
Masking
Participant
Masking Description
Participant will not know which type of block they receive
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESP Nerve Block for Renal colic
Arm Type
Active Comparator
Arm Description
On top of receiving standard of care, At T8 nerve level, with ultrasound guidance to bathe the nerve
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Whatever medications the clinician normally treats renal colic with
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
Local anesthesia injected under ultrasound guidance
Intervention Type
Other
Intervention Name(s)
Standard of care medications
Intervention Description
Whatever the ED clinicians normally give for renal colic pain
Primary Outcome Measure Information:
Title
Baseline Pain before intervention
Description
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Time Frame
Before the ESP Block
Title
Pain score at 10 minutes
Description
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Time Frame
10 minutes after the ESP Block
Title
Pain score at 20 minutes
Description
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Time Frame
20 minutes after ESP Block
Title
Pain score at 40 minutes
Description
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
Time Frame
40 minutes after ESP Block
Title
Pain score at 60 minutes
Description
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
Time Frame
60 minutes after ESP Block
Secondary Outcome Measure Information:
Title
Need for extra opiates
Description
Record how much opioids patients receives starting after the ESP Block for both the "standard of care" patients and the ESP Block group
Time Frame
Starting from time 0 after the ESP Block intervention completed till discharge or urology intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilbert Tetteh, MD
Phone
631-459-9701
Email
Gilbert.tetteh@stonybrookmedicine.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Secko, MD
Organizational Affiliation
StonyBrook University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
StonyBrook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Secko, MD
Phone
631-645-7200
Email
Mseckomd@gmail.com
First Name & Middle Initial & Last Name & Degree
Gilbert Tetteh, MD
Phone
9173001494
Email
gtetteh08@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33099855
Citation
Aydin ME, Tekin E, Ahiskalioglu EO, Ates I, Karagoz S, Aydin OF, Ozkaya F, Ahiskalioglu A. Erector spinae plane block vs non-steroidal anti-inflammatory drugs for severe renal colic pain: A pilot clinical feasibility study. Int J Clin Pract. 2021 Mar;75(3):e13789. doi: 10.1111/ijcp.13789. Epub 2020 Nov 9.
Results Reference
background
Learn more about this trial
Erector Spinae Plane (ESP) Block for Renal Colic
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