Erector Spinae Plane Block for Acute Back Pain in the Emergency Department

NCT ID: NCT06745453

Last Updated: 2025-03-10

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

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2026-06-30

Brief Summary

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The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are:

1. Does the ESPB reduce short-term pain in participants with low back pain?
2. Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain?

Researchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain.

Participants will:

Receive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Erector Spinae Plane Block

This group will receive the erector spinae plane block

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type PROCEDURE

Erector Spinae Plane Block

Sham Procedure

This group will receive a sham injection.

Group Type SHAM_COMPARATOR

Sham Procedure

Intervention Type PROCEDURE

Sham Procedure

Interventions

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Erector Spinae Plane Block

Erector Spinae Plane Block

Intervention Type PROCEDURE

Sham Procedure

Sham Procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.

Exclusion Criteria

* Do not speak English or Spanish as a primary language
* Are incarcerated
* Have a known pregnancy
* Are allergic to amide-type local anesthetics
* Are unable to tolerate positioning for the procedure
* Have a critical illness precluding the ability to perform the procedure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Gottlieb

Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Gottlieb, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aylin Ornelas Loredo, MMS

Role: CONTACT

312-563-0645

Michelle Santangelo, MS

Role: CONTACT

312-563-0645

Facility Contacts

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Aylin Ornelas Loredo, MMS

Role: primary

312-563-0645

Michelle Santangelo, MS

Role: backup

312-563-0645

Other Identifiers

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24062802

Identifier Type: -

Identifier Source: org_study_id

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