Back to resultsErector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain
Primary Purpose
Back Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Erector Spinae plane block using 20 ml of bupivicaine 0.25%
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring nerve block, back pain, regional anaesthesia, analgesia
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
Sites / Locations
- Nanaimo Regional General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ESP cohort
Usual care cohort
Arm Description
Randomized to receive the ultrasound-guided ESP block.
Randomized to usual care as dictated by the treating emergency physician
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use
Opiate medication dose and route of administration was recorded
Emergency department (ED) length of stay.
Time spent in the emergency department.
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
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.
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05982483
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 8, 2019 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
January 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Island Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
nerve block, back pain, regional anaesthesia, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Participants in both cohorts had pink chlorhexidine skin prep and a dressing applied to the back. Research team members performing the telephone follow-up were blinded to treatment allocation.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESP cohort
Arm Type
Experimental
Arm Description
Randomized to receive the ultrasound-guided ESP block.
Arm Title
Usual care cohort
Arm Type
Active Comparator
Arm Description
Randomized to usual care as dictated by the treating emergency physician
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae plane block using 20 ml of bupivicaine 0.25%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Usual care
Intervention Description
Analgesia as dictated by the treating emergency physician
Primary Outcome Measure Information:
Title
Numeric Verbal Pain Score (NVPS) reduction at emergency department discharge
Description
The NVPS is an 11-point verbal pain scale from 0 to 10 with 0 representing no pain and 10 the worst pain imaginable.
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.
Secondary Outcome Measure Information:
Title
Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use
Description
Opiate medication dose and route of administration was recorded
Time Frame
Time of randomization to time of ED discharge up to 24 hours after randomization.
Title
Emergency department (ED) length of stay.
Description
Time spent in the emergency department.
Time Frame
Time of ED triage to time of ED discharge up to 24 hours after triage.
Title
Brief Pain Inventory (BPI) score reduction from baseline
Description
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 Frame
Time of randomization compared to 1 day, 1 week, 1 month, and 3 months post Emergency department visit
Title
Number of patients requiring post Emergency department discharge opiate analgesia use
Description
During telephone follow up, patients were asked if there was any opiate analgesia used during the pre-determined time period.
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.
Title
Post Emergency department (ED) discharge Numeric Verbal Pain Score (NVPS)
Description
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
Time Frame
1 day after randomization, 1 week after randomization, 1 month after randomization, 3 months after randomization.
Title
Number of patients able to ambulate post ED treatment if unable to on ED admission
Description
If patient was unable to ambulate on ED admission, did ED treatment allow ambulation without assistance: yes or no
Time Frame
Time of ED triage compared to time of ED discharge up to 24 hours after triage.
Title
Number of patients requiring Emergency department (ED) return visits for back pain
Description
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
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nanaimo Regional General Hospital
City
Nanaimo
State/Province
British Columbia
ZIP/Postal Code
V9S2B7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain
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