Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-08

Study Completion Date

2023-01-16

Brief Summary

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The goal of this clinical trial is to compare the Erector Spinae plane (ESP) block, a nerve block, to usual care in emergency department patients with back pain. The main question it aims to answer:

Is the ESP block superior to usual care in the treatment of back pain in the emergency department? Participants will be randomly assigned to the ESP or the usual care group. Pain improvement at the time of emergency department discharge will be compared.

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Detailed Description

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Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Participants in both cohorts had pink chlorhexidine skin prep and a dressing applied to the back. Research team members performing the telephone follow-up were blinded to treatment allocation.

Study Groups

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ESP cohort

Randomized to receive the ultrasound-guided ESP block.

Group Type EXPERIMENTAL

Erector Spinae plane block using 20 ml of bupivicaine 0.25%

Intervention Type PROCEDURE

Utilizing the in line approach, a 22 gauge 3.5" spinal needle was guided the the tip of the transverse process corresponding to the area of maximal tenderness or central to the reported area of spasm. 1% lidocaine with epinephrine was used for skin anaesthesia and for hydro-localization of the needle tip on approach to the tip of the transverse process. Once the needle tip made contact with the transverse process, 2-3 ml of 1% lidocaine with epinephrine was injected to open the ESP plane. If there was no reported tachycardia after approximately 45 seconds, 20 ml of 0.25% bupivicaine was injected into the ESP plane.

Usual care cohort

Randomized to usual care as dictated by the treating emergency physician

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type DRUG

Analgesia as dictated by the treating emergency physician

Interventions

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Erector Spinae plane block using 20 ml of bupivicaine 0.25%

Utilizing the in line approach, a 22 gauge 3.5" spinal needle was guided the the tip of the transverse process corresponding to the area of maximal tenderness or central to the reported area of spasm. 1% lidocaine with epinephrine was used for skin anaesthesia and for hydro-localization of the needle tip on approach to the tip of the transverse process. Once the needle tip made contact with the transverse process, 2-3 ml of 1% lidocaine with epinephrine was injected to open the ESP plane. If there was no reported tachycardia after approximately 45 seconds, 20 ml of 0.25% bupivicaine was injected into the ESP plane.

Intervention Type PROCEDURE

Usual care

Analgesia as dictated by the treating emergency physician

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* previous recipient of erector spinae plane block
* exam concerning for cauda equina syndrome
* current IV drug use
* organ transplant recipient
* history of or suspected bleeding diathesis
* current use of anticoagulants
* sepsis or soft tissue infection at site of the block within last three months
* pregnancy
* overt malignancy involving skin or underlying soft tissue at the site of block
* allergy to any of the research medications
* inability to participate in telephone follow-up

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No