Erector Spinae Plane (ESP) Block for Renal Colic

NCT ID: NCT05323175

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2025-06-01

Brief Summary

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

Detailed Description

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

Conditions

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Renal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Standard of care group + sham normal saline ESP block vs Standard of care + Ropivacaine ESP nerve Block group
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participant will not know which type of block they receive

Study Groups

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ESP Nerve Block for Renal colic

On top of receiving standard of care, At T8 nerve level, with ultrasound guidance to bathe the nerve

Group Type ACTIVE_COMPARATOR

Ropivacaine injection

Intervention Type DRUG

Local anesthesia injected under ultrasound guidance

Standard of care

Whatever medications the clinician normally treats renal colic with

Group Type ACTIVE_COMPARATOR

Standard of care medications

Intervention Type OTHER

Whatever the ED clinicians normally give for renal colic pain

Interventions

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Ropivacaine injection

Local anesthesia injected under ultrasound guidance

Intervention Type DRUG

Standard of care medications

Whatever the ED clinicians normally give for renal colic pain

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Michael Secko, MD

Clinical Associate Professor, Emergency Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Secko, MD

Role: PRINCIPAL_INVESTIGATOR

StonyBrook University Hospital

Locations

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StonyBrook University Hospital

Stony Brook, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33099855 (View on PubMed)

Other Identifiers

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IRB2021-00518

Identifier Type: -

Identifier Source: org_study_id

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