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Trial registered on ANZCTR


Registration number
ACTRN12618001872224
Ethics application status
Approved
Date submitted
17/10/2018
Date registered
16/11/2018
Date last updated
10/11/2020
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does erector spinae block effect somatosensory evoked potentials in volunteers?
Scientific title
Does erector spinae block(ESB) effect somatosensory evoked potentials (SSEPs) in healthy volunteers?
Secondary ID [1] 296351 0
Nil known
Universal Trial Number (UTN)
U1111-1222-4638
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia 310078 0
Condition category
Condition code
Anaesthesiology 308828 308828 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 healthy volunteers will have a single shot erector spinae block administered by an experienced regional anaesthetist. The block will be undertaken in the recovery room with the usual ANZCA mandated monitoring for a major regional anaesthesia block (ECG, BP and pulse oximetry). 30ml of 0.375% ropivacaine will be used for the erector spinae block which will be undertaken under ultrasound guidance, with the local injected under the erector spinae muscles at the T4-T5 level. Somatasensory evoked potentials will be measured in the dermatomes, at the level of the block and 3 levels either side of the block, to account for potential spread of the block. The somatosensory evoked potential monitoring will be undertaken by a neurophysiology company experienced in the monitoring of somatosensory evoked potentials for spinal surgery.
Intervention code [1] 312685 0
Treatment: Other
Intervention code [2] 312741 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307802 0
Amplitude of somatosensory evoked potentials at the dermatomal level of the erector spinae block as assessed by stimulation of the intercostal nerves with a constant current generator and assessed by scalp electrode monitoring of the electroencephalogram.
Timepoint [1] 307802 0
Baseline, 15 minutes and 30 minutes after institution of the block
Secondary outcome [1] 352962 0
Following institution of the erector spinae block, changes in the participants sensory response to an ice pack will be mapped out, the patient will report where the sensation is altered to determine the extent of the block. The dermatomal innervation of the skin is well known, and therefore the extent of the block can be determined by a reduction in the sensation of cold, when an ice pack is pressed to the skin. This is a well recognised way of assessing regional anaesthesia efficacy (e.g. in patients with an epidural), and will be undertaken by experienced recovery nurses.
Timepoint [1] 352962 0
15 and 30 minutes after institution of the block

Eligibility
Key inclusion criteria
Healthy volunteers who have no contraindication to receiving local anaesthetic or an erector spinae block and who have signed written consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy to local anaesthetic
Infection at the site of proposed nerve block

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil required
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil required
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics only, percentage of patients were SSEPs are abolished, and dermatomal spread of the block in each subject.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/01/2019
Actual
30/03/2019
Date of last participant enrolment
Anticipated
1/02/2019
Actual
30/03/2019
Date of last data collection
Anticipated
1/02/2019
Actual
30/03/2019
Sample size
Target
10
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 20938 0
New Zealand
State/province [1] 20938 0
Waikato

Funding & Sponsors
Funding source category [1] 300956 0
Hospital
Name [1] 300956 0
The Waikato hospital department of anaesthesia research fund
Country [1] 300956 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato hospital
Address
Pembroke Street
Hamilton 3204
New Zealand
Country
New Zealand
Secondary sponsor category [1] 300528 0
None
Name [1] 300528 0
Address [1] 300528 0
Country [1] 300528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301721 0
National Health and Disability Ethics Committee
Ethics committee address [1] 301721 0
Ethics committee country [1] 301721 0
New Zealand
Date submitted for ethics approval [1] 301721 0
02/12/2018
Approval date [1] 301721 0
19/02/2019
Ethics approval number [1] 301721 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87882 0
Dr Kelly Byrne
Address 87882 0
Department of Anaesthesia
Level 4 Waiora Building
Waikato Hospital
Hamilton 3204
New Zealand
Country 87882 0
New Zealand
Phone 87882 0
+64 2102224390
Fax 87882 0
Email 87882 0
kpa.byrne@gmail.com
Contact person for public queries
Name 87883 0
Kelly Byrne
Address 87883 0
Department of Anaesthesia
Level 4 Waiora Building
Waikato Hospital
Hamilton 3204
New Zealand
Country 87883 0
New Zealand
Phone 87883 0
+64 2102224390
Fax 87883 0
Email 87883 0
kpa.byrne@gmail.com
Contact person for scientific queries
Name 87884 0
Kelly Byrne
Address 87884 0
Department of Anaesthesia
Level 4 Waiora Building
Waikato Hospital
Hamilton 3204
New Zealand
Country 87884 0
New Zealand
Phone 87884 0
+64 2102224390
Fax 87884 0
Email 87884 0
kpa.byrne@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHuman volunteer study examining the sensory changes of the thorax after an erector spinae plane block.2020https://dx.doi.org/10.1136/rapm-2019-101019
N.B. These documents automatically identified may not have been verified by the study sponsor.