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Completed

NCT Number: NCT05982483

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanaimo Regional General Hospital

Nanaimo, British Columbia, V9S2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Drug

Analgesia as dictated by the treating emergency physician

Primary outcomes

  1. 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

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

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

    Opiate medication dose and route of administration was recorded

  2. Emergency department (ED) length of stay.

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

    Time spent in the emergency department.

  3. Brief Pain Inventory (BPI) score reduction from baseline

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

    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

  4. Number of patients requiring post Emergency department discharge opiate analgesia use

    Time frame: 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.

    During telephone follow up, patients were asked if there was any opiate analgesia used during the pre-determined time period.

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

    Time frame: 1 day after randomization, 1 week after randomization, 1 month after randomization, 3 months after randomization.

    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

  6. Number of patients able to ambulate post ED treatment if unable to on ED admission

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

    If patient was unable to ambulate on ED admission, did ED treatment allow ambulation without assistance: yes or no

  7. Number of patients requiring Emergency department (ED) return visits for back pain

    Time frame: 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.

    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

Sponsors and collaborators

Lead sponsor

Island Health

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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