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

Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Procedure: Erector Spinae plane block using 20 ml of bupivicaine 0.25%; Drug: Usual care

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Nanaimo, British Columbia, Canada, V9S2B7
      • Nanaimo Regional General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Patients deemed to have mechanical back pain with a component of paravertebral tenderness or paravertebral spasm reported by the patient or noted on examination by treating physician.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP cohort; Randomized to receive the ultrasound-guided ESP block.	Procedure: 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.
Active Comparator: Usual care cohort; Randomized to usual care as dictated by the treating emergency physician	Drug: Usual care; Analgesia as dictated by the treating emergency physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use	Opiate medication dose and route of administration was recorded	Time of randomization to time of ED discharge up to 24 hours after randomization.
Emergency department (ED) length of stay.	Time spent in the emergency department.	Time of ED triage to time of ED discharge up to 24 hours after triage.
Brief Pain Inventory (BPI) score reduction from baseline	The Brief Pain Inventory (BPI) is widely used to measure a patients' pain intensity and interference the pain has on daily function measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10with 0 representing no interference and 10 complete interference in that aspect of life. The initial BPI was recorded at time of randomization and subsequent BPI's recorded by telephone follow-up at predetermined time intervals	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	During telephone follow up, patients were asked if there was any opiate analgesia used during the pre-determined time period.	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)	At telephone follow up at predetermined time intervals, patients were asked what their most severe level of pain they were currently experiencing as measured by the NVPS	1 day after randomization, 1 week after randomization, 1 month after randomization, 3 months after randomization.
Number of patients able to ambulate post ED treatment if unable to on ED admission	If patient was unable to ambulate on ED admission, did ED treatment allow ambulation without assistance: yes or no	Time of ED triage compared to time of ED discharge up to 24 hours after triage.
Number of patients requiring Emergency department (ED) return visits for back pain	At telephone follow up at predetermined intervals, patients were asked if they had to return subsequently to the emergency department due to their back pain	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.

Collaborators and Investigators

• Sponsor: Island Health

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2019
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): January 16, 2023

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: back pain; nerve block; analgesia; regional anaesthesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: C2018-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No