An interventional study of Erector Spinae plane block using 20 ml of bupivicaine 0.25% and Usual care in Back Pain, sponsored by Island Health. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by Island Health · Not applicable, Interventional, and Treatment
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.
2,389 studies on the registry are indexed under Back Pain; 282 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 1,952 interventional studies indexed under Back Pain.
Browse Back Pain studies →This is the only study on the registry with Island Health as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
Randomized to receive the ultrasound-guided ESP block.
Procedure: Erector Spinae plane block using 20 ml of bupivicaine 0.25%
Randomized to usual care as dictated by the treating emergency physician
Drug: Usual care
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.
Analgesia as dictated by the treating emergency physician
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.
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.
Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use
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.
Emergency department (ED) length of stay.
Time spent in the emergency department.
Time frame: Time of ED triage to time of ED discharge up to 24 hours after triage.
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 frame: 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
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.
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
Time frame: 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
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.
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
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.
Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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