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Clinical Trials/NCT05982483
NCT05982483
Completed
Not Applicable

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

Island Health1 site in 1 country30 target enrollmentSeptember 8, 2019

Overview

Phase
Not Applicable
Intervention
Erector Spinae plane block using 20 ml of bupivicaine 0.25%
Conditions
Back Pain
Sponsor
Island Health
Enrollment
30
Locations
1
Primary Endpoint
Numeric Verbal Pain Score (NVPS) reduction at emergency department discharge
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 8, 2019
End Date
January 16, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ben Ho

Emergency department staff physician

Island Health

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

Arms & Interventions

ESP cohort

Randomized to receive the ultrasound-guided ESP block.

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

Usual care cohort

Randomized to usual care as dictated by the treating emergency physician

Intervention: Usual care

Outcomes

Primary Outcomes

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

Time Frame: 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.

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

Secondary Outcomes

  • 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.)
  • Number of patients able to ambulate post ED treatment if unable to on ED admission(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(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.)

Study Sites (1)

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