Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date results information initially provided
10/11/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Does erector spinae block effect somatosensory evoked potentials in volunteers?
Query!
Scientific title
Does erector spinae block(ESB) effect somatosensory evoked potentials (SSEPs) in healthy volunteers?
Query!
Secondary ID [1]
296351
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1222-4638
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Analgesia
310078
0
Query!
Condition category
Condition code
Anaesthesiology
308828
308828
0
0
Query!
Pain management
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
312685
0
Treatment: Other
Query!
Intervention code [2]
312741
0
Treatment: Drugs
Query!
Comparator / control treatment
No control group.
Query!
Control group
Uncontrolled
Query!
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.
Query!
Assessment method [1]
307802
0
Query!
Timepoint [1]
307802
0
Baseline, 15 minutes and 30 minutes after institution of the block
Query!
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.
Query!
Assessment method [1]
352962
0
Query!
Timepoint [1]
352962
0
15 and 30 minutes after institution of the block
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Allergy to local anaesthetic
Infection at the site of proposed nerve block
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil required
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil required
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Descriptive statistics only, percentage of patients were SSEPs are abolished, and dermatomal spread of the block in each subject.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
14/01/2019
Query!
Actual
30/03/2019
Query!
Date of last participant enrolment
Anticipated
1/02/2019
Query!
Actual
30/03/2019
Query!
Date of last data collection
Anticipated
1/02/2019
Query!
Actual
30/03/2019
Query!
Sample size
Target
10
Query!
Accrual to date
Query!
Final
6
Query!
Recruitment outside Australia
Country [1]
20938
0
New Zealand
Query!
State/province [1]
20938
0
Waikato
Query!
Funding & Sponsors
Funding source category [1]
300956
0
Hospital
Query!
Name [1]
300956
0
The Waikato hospital department of anaesthesia research fund
Query!
Address [1]
300956
0
Department of Anaesthesia
Level 4 Waiora buliding
Waikato hospital
Pembroke Street
Hamilton 3204
New Zealand
Query!
Country [1]
300956
0
New Zealand
Query!
Primary sponsor type
Hospital
Query!
Name
Waikato hospital
Query!
Address
Pembroke Street
Hamilton 3204
New Zealand
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
300528
0
None
Query!
Name [1]
300528
0
Query!
Address [1]
300528
0
Query!
Country [1]
300528
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
301721
0
National Health and Disability Ethics Committee
Query!
Ethics committee address [1]
301721
0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Query!
Ethics committee country [1]
301721
0
New Zealand
Query!
Date submitted for ethics approval [1]
301721
0
02/12/2018
Query!
Approval date [1]
301721
0
19/02/2019
Query!
Ethics approval number [1]
301721
0
Query!
Summary
Brief summary
The erector spinae block is a newly described regional anaesthetic technique which has the potential to be applied to a wide range of surgeries. It is potentially an alternative to a paravertebral block, an older, effective but much more technically difficult block. One of the benefits of the paravertebral block is that it profoundly blocks the somatosensory evoked potentials of the area that it provides analgesia to[Richardson, et al. The Effect of thoracic paravertebral blockade on Intercostal somatosensory evoked potentials. Anesth Analg 1998:87;373-76]. This potentially reduces the stress response to surgery, and the likelihood of chronic pain following surgery.
For the erector spinae block to replace the paravertebral block in clinical practice, it is important to show that it is not only equivalent in terms of analgesia, but should also be equivalent in its ability to block the somatosensory evoked potentials.
The aim of this study is to determine whether or not the erector spinae block effects somatosensory evoked potentials in healthy volunteers.
Query!
Trial website
Nil
Query!
Trial related presentations / publications
Nil
Query!
Public notes
Nil
Query!
Contacts
Principal investigator
Name
87882
0
Dr Kelly Byrne
Query!
Address
87882
0
Department of Anaesthesia
Level 4 Waiora Building
Waikato Hospital
Hamilton 3204
New Zealand
Query!
Country
87882
0
New Zealand
Query!
Phone
87882
0
+64 2102224390
Query!
Fax
87882
0
Query!
Email
87882
0
[email protected]
Query!
Contact person for public queries
Name
87883
0
Dr Kelly Byrne
Query!
Address
87883
0
Department of Anaesthesia
Level 4 Waiora Building
Waikato Hospital
Hamilton 3204
New Zealand
Query!
Country
87883
0
New Zealand
Query!
Phone
87883
0
+64 2102224390
Query!
Fax
87883
0
Query!
Email
87883
0
[email protected]
Query!
Contact person for scientific queries
Name
87884
0
Dr Kelly Byrne
Query!
Address
87884
0
Department of Anaesthesia
Level 4 Waiora Building
Waikato Hospital
Hamilton 3204
New Zealand
Query!
Country
87884
0
New Zealand
Query!
Phone
87884
0
+64 2102224390
Query!
Fax
87884
0
Query!
Email
87884
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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
Source
Title
Year of Publication
DOI
Embase
Human volunteer study examining the sensory changes of the thorax after an erector spinae plane block.
2020
https://dx.doi.org/10.1136/rapm-2019-101019
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF