Clinical trial NCT05982483: Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain
Official title: Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: nerve block
back pain
regional anaesthesia
analgesia
Lead sponsor: Island Health
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Numeric Verbal Pain Score (NVPS) reduction at emergency department discharge
timeFrame: 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:
measure: Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use
timeFrame: Time of randomization to time of ED discharge up to 24 hours after randomization.
measure: Emergency department (ED) length of stay.
timeFrame: Time of ED triage to time of ED discharge up to 24 hours after triage.
measure: Brief Pain Inventory (BPI) score reduction from baseline
timeFrame: Time of randomization compared to 1 day, 1 week, 1 month, and 3 months post Emergency department visit
measure: Number of patients requiring post Emergency department discharge opiate analgesia use
timeFrame: 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.
measure: Post Emergency department (ED) discharge Numeric Verbal Pain Score (NVPS)
timeFrame: 1 day after randomization, 1 week after randomization, 1 month after randomization, 3 months after randomization.
measure: Number of patients able to ambulate post ED treatment if unable to on ED admission
timeFrame: Time of ED triage compared to time of ED discharge up to 24 hours after triage.
measure: Number of patients requiring Emergency department (ED) return visits for back pain
timeFrame: 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.
Other outcomes:
Locations:
city: Nanaimo
country: Canada
facility: Nanaimo Regional General Hospital
state: British Columbia
Study officials:
References: