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

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05982483
• Other study ID #: C2018-102
• Status: Completed
• Phase: N/A
• Start date: September 8, 2019
• Est. completion date: January 16, 2023

Study information

• Verified date: August 2023
• Source: Island Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 16, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

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.

Drug:
• Usual care
Analgesia as dictated by the treating emergency physician

Locations

Country	Name	City	State
Canada	Nanaimo Regional General Hospital	Nanaimo	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Island Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.