Back PainNCT05982483
Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain
A study testing Erector Spinae plane block using 20 ml of bupivicaine 0.25% in people with Back Pain, run by Island Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Erector Spinae plane block using 20 ml of bupivicaine 0.25%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2019to 16 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Nanaimo Regional General Hospital
Nanaimo, British Columbia, V9S2B7
About this study
Official title: Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain: A Randomized Controlled Trial
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.
- Conditions
- Back Pain
- Being tested
- Erector Spinae plane block using 20 ml of bupivicaine 0.25%, Usual care
- Keywords
- nerve block, back pain, regional anaesthesia, analgesia
- Medical subject headings
- Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae plane block using 20 ml of bupivicaine 0.25%Procedure or surgery
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 careDrug
Analgesia as dictated by the treating emergency physician
| Study group | Role | What they receive |
|---|---|---|
| ESP cohort | Experimental | Randomized to receive the ultrasound-guided ESP block. Receives: Procedure: Erector Spinae plane block using 20 ml of bupivicaine 0.25% |
| Usual care cohort | Active comparator | Randomized to usual care as dictated by the treating emergency physician Receives: Drug: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (7)
Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use
Opiate medication dose and route of administration was recorded
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start8 Sep 2019
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Island Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Ho, Island Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982483
- Sponsor's protocol ID
- C2018-102
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ho B, Fyfe-Brown R, Chopra S, McMeel K. The erector spinae plane block vs. usual care for treatment of mechanical back pain in the emergency department: a pilot study. CJEM. 2024 Aug;26(8):543-548. doi: 10.1007/s43678-024-00748-7. Epub 2024 Jul 31.
PubMed 39083200
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05982483
- Acronym / sponsor ID
- C2018-102
- Conditions
- Back Pain
- Keywords
- nerve block, back pain, regional anaesthesia, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Island HealthUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP cohort | Experimental | Procedure: Erector Spinae plane block using 20 ml of bupivicaine 0.25%Randomized to receive the ultrasound-guided ESP block. |
| Usual care cohort | Active comparator | Drug: Usual careRandomized to usual care as dictated by the treating emergency physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae plane block using 20 ml of bupivicaine 0.25%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. | Procedure or surgery | ESP cohort |
| Usual careAnalgesia as dictated by the treating emergency physician | Drug | Usual care cohort |
Primary outcome
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.
7 secondary outcomes
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.
Emergency department (ED) length of stay.
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
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
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)
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 39083200Ho B, Fyfe-Brown R, Chopra S, McMeel K. The erector spinae plane block vs. usual care for treatment of mechanical back pain in the emergency department: a pilot study. CJEM. 2024 Aug;26(8):543-548. doi: 10.1007/s43678-024-00748-7. Epub 2024 Jul 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae plane block using 20 ml of bupivicaine 0.25% in people with Back Pain, run by Island Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.