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

NCT05982483 | Completed

• 1 other identifier: C2018-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain

Keywords

nerve block; back pain; regional anaesthesia; analgesia

Outcome Measures

Primary Outcomes (1)

• Numeric Verbal Pain Score (NVPS) reduction at emergency department discharge

  The NVPS is an 11-point verbal pain scale from 0 to 10 with 0 representing no pain and 10 the worst pain imaginable.

  Numeric verbal pain score (NVPS) at time of randomization compared with NVPS at time of discharge from the emergency department up to 24 hours after randomization.

Secondary Outcomes (7)

• Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use

  Time of randomization to time of ED discharge up to 24 hours after randomization.

• Emergency department (ED) length of stay.

  Time of ED triage to time of ED discharge up to 24 hours after triage.

• Brief Pain Inventory (BPI) score reduction from baseline

  Time of randomization compared to 1 day, 1 week, 1 month, and 3 months post Emergency department visit

• Number of patients requiring post Emergency department discharge opiate analgesia use

  Date of randomization to 1 day after randomization, 1 day after randomization to 1 week after randomization, 1week after randomization to 1 month after randomization, 1 month after randomization to 3 months after randomization.

• Post Emergency department (ED) discharge Numeric Verbal Pain Score (NVPS)

  1 day after randomization, 1 week after randomization, 1 month after randomization, 3 months after randomization.

Study Arms (2)

ESP cohort

EXPERIMENTAL

Randomized to receive the ultrasound-guided ESP block.

Procedure: Erector Spinae plane block using 20 ml of bupivicaine 0.25%

Usual care cohort

ACTIVE COMPARATOR

Randomized to usual care as dictated by the treating emergency physician

Drug: Usual care

Interventions

Erector Spinae plane block using 20 ml of bupivicaine 0.25% 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.

ESP cohort

Usual care DRUG

Analgesia as dictated by the treating emergency physician

Usual care cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Island Health: lead

Study Sites (1)

Nanaimo Regional General Hospital

Nanaimo, British Columbia, V9S2B7, Canada

Location

Related Publications (1)

• Ho B, Fyfe-Brown R, Chopra S, McMeel K. The erector spinae plane block vs. usual care for treatment of mechanical back pain in the emergency department: a pilot study. CJEM. 2024 Aug;26(8):543-548. doi: 10.1007/s43678-024-00748-7. Epub 2024 Jul 31.

  PMID: 39083200 DERIVED

MeSH Terms

Conditions

Back Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency department staff physician

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 8, 2023
• Study Start: September 8, 2019
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)