NCT05323175

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2026

Completed
Last Updated

June 3, 2026

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

October 8, 2021

Last Update Submit

June 1, 2026

Conditions

Renal Colic

Keywords

Erector spinae plane block

Outcome Measures

Primary Outcomes (5)

  • Baseline Pain before intervention

    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

    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

    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

    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

    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 Outcomes (1)

  • Need for extra opiates

    Starting from time 0 after the ESP Block intervention completed till discharge or urology intervention

Study Arms (2)

ESP Nerve Block for Renal colic

ACTIVE COMPARATOR

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

Drug: Ropivacaine injection

Standard of care

ACTIVE COMPARATOR

Whatever medications the clinician normally treats renal colic with

Other: Standard of care medications

Interventions

Ropivacaine injectionDRUG

Local anesthesia injected under ultrasound guidance

ESP Nerve Block for Renal colic
Standard of care medicationsOTHER

Whatever the ED clinicians normally give for renal colic pain

Standard of care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years old
  • ASA Level I and II
  • flank pain concerning for renal colic in ED

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

StonyBrook University Hospital

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

  • 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.

    PMID: 33099855BACKGROUND

MeSH Terms

Conditions

Renal Colic

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Michael Secko, MD

    StonyBrook University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will not know which type of block they receive
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Standard of care group + sham normal saline ESP block vs Standard of care + Ropivacaine ESP nerve Block group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor, Emergency Department

Study Record Dates

First Submitted

October 8, 2021

First Posted

April 12, 2022

Study Start

April 25, 2022

Primary Completion

January 9, 2026

Study Completion

January 9, 2026

Last Updated

June 3, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)