Erector Spinae Plane (ESP) Block for Renal Colic

Sponsor

Stony Brook University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05323175

Collaborator

(none)

Enrollment

Location

Arms

14.2

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparing standard of care to erector spinae plane block for acute renal colic pain.

Condition or Disease	Intervention/Treatment	Phase
Renal Colic	Drug: Ropivacaine injection Other: Standard of care medications	Phase 4

Detailed Description

Will compare at times 0, 10 minute, 20 minute, 40 minute and 60 minutes after local nerve block given.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Standard of care group + sham normal saline ESP block vs Standard of care + Ropivacaine ESP nerve Block groupStandard of care group + sham normal saline ESP block vs Standard of care + Ropivacaine ESP nerve Block group

Masking:

Single (Participant)

Masking Description:

Participant will not know which type of block they receive

Primary Purpose:

Other

Official Title:

Can Erector Spinae Plane (ESP) Block Better Relieve Acute Renal Colic Pain Than Standard of Care

Actual Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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	Drug: Ropivacaine injection Local anesthesia injected under ultrasound guidance
Active Comparator: Standard of care Whatever medications the clinician normally treats renal colic with	Other: Standard of care medications Whatever the ED clinicians normally give for renal colic pain

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

Drug: Ropivacaine injection

Local anesthesia injected under ultrasound guidance

Active Comparator: Standard of care

Whatever medications the clinician normally treats renal colic with

Other: Standard of care medications

Whatever the ED clinicians normally give for renal colic pain

Outcome Measures

Primary Outcome Measures

Baseline Pain before intervention [Before the ESP Block]
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Pain score at 10 minutes [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"
Pain score at 20 minutes [20 minutes after ESP Block]
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Pain score at 40 minutes [40 minutes after ESP Block]
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
Pain score at 60 minutes [60 minutes after ESP Block]
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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	StonyBrook University Hospital	Stony Brook	New York	United States	11794

Sponsors and Collaborators

Stony Brook University

Investigators

Principal Investigator: Michael Secko, MD, StonyBrook University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Gilbert Tetteh, Medical Doctor, Emergency Department Attending, Stony Brook University

ClinicalTrials.gov Identifier:

NCT05323175

Other Study ID Numbers:

IRB2021-00518

First Posted:

Apr 12, 2022

Last Update Posted:

Jun 3, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gilbert Tetteh, Medical Doctor, Emergency Department Attending, Stony Brook University

Erector spinae plane block

Additional relevant MeSH terms:

Colic

Renal Colic

Ropivacaine

Study Results

No Results Posted as of Jun 3, 2022