Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001197426
Ethics application status
Approved
Date submitted
28/08/2016
Date registered
30/08/2016
Date last updated
30/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Visual images to assist in positioning for spinal and epidural anaesthesia
Scientific title
Usefulness of visual aids in achieving optimal positioning for neuraxial anaesthesia: a randomised trial.
Secondary ID [1] 290034 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
neuraxial anaesthesia 300076 0
Condition category
Condition code
Anaesthesiology 299961 299961 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients undergoing neuraxial anaesthesia for their hip and knee replacements, were randomised into two groups: The intervention group( Group 2) received standardised verbal instructions along with visual images to assist them to appropriate positioning to enable a spinal block.
Following intravenous cannulation and application of standard monitoring, the participants were requested to sit in the upright position on the operating table with their feet resting on a stool, and shoulders gently supported by an assistant. No further assistance in positioning or any verbal prompting was provided by the theatre assistant. No sedative or anxiolytic premedication was administered to the participants, due to possible interference with their comprehension. Anaesthetists were allowed to choose the type, level, and approach of the block, as well as the needle and local anaesthetic used.
The anaesthetist prepared the spinal tray and drugs under aseptic conditions, and prepared and draped the patient’s back. A second person started the timer and read out the standardised verbal instructions and showed the visual images (with a model demonstrating one correct and three incorrect positions).The patient then adopted the required position, and the anaesthetist immediately commenced the procedure. A trained independent observer recorded the relevant data.
Intervention code [1] 295757 0
Treatment: Other
Comparator / control treatment
The control group( Group 1) received standardised verbal instructions to assist them to appropriate positioning to enable a spinal block. These verbal instructions were drafted based on the common phrases used by anaesthetists to get their patients positioned for spinal anaesthesia.The patient then adopted the required position, and the anaesthetist immediately commenced the procedure. A trained independent observer recorded the relevant data.
Control group
Active

Outcomes
Primary outcome [1] 299449 0
Time taken to achieve a successful dural puncture
Timepoint [1] 299449 0
The timer would start when the anaesthetist commences the spinal anaesthetic and would stop when there is free flow of CSF.
Secondary outcome [1] 327200 0
Secondary endpoints included number of skin punctures (not including local anaesthetic infiltration) until successful dural puncture
Timepoint [1] 327200 0
Total number of skin punctures until there is free flow of CSF through the needle
Secondary outcome [2] 327241 0
Success at the first attempted intervertebral space. Success is defined by the CSF flow through the needle.
Timepoint [2] 327241 0
The time point when there was CSF flow through the needle
Secondary outcome [3] 327242 0
Satisfaction scores for anaesthetist from 1 to 5, 1 being very dissatisfied to 5 being completely satisfied
Timepoint [3] 327242 0
Immediately after the procedure
Secondary outcome [4] 327243 0
Satisfaction scores for the patient from 1 to 5, 1 being very dissatisfied to 5 being completely satisfied
Timepoint [4] 327243 0
Immediately after the procedure

Eligibility
Key inclusion criteria
Adult patients undergoing elective hip and knee replacements under spinal anaesthesia were eligible for inclusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were refusal to consent, inability to read or comprehend English, any contraindication to neuraxial anaesthesia, prior experience with neuraxial blocks, body mass index (BMI) greater than 45 kg/m2, anticipated positioning difficulties due to severe arthritis or major spinal deformities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocation was achieved by means of double opaque, sealed envelopes marked with trial identification numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants were randomly allocated into two equal groups, based on computer generated random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences between continuous variables such as age, height, weight and body mass index will be by Student’s t-test or analysis of variance as appropriate. Comparison of categorical variables such as sex, number of skin punctures, number of spaces attempted, and level of experience will be done using Pearson’s chi-squared test of independence. Comparison of ordinal variables such as satisfaction levels between groups will be done using appropriate non-parametric tests. Logistic regression will be used to assess association between continuous variables and binary outcomes such as success at first attempt.
A sample size of approximately 43 patients per arm is proposed, based on obtaining 90% power to detect a difference 2.5 minutes between average times for the two treatment groups, using a 5% significance level and based on standard deviation of approximately 3.525 minutes. The level of significance will be set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
29/06/2016
Date of last data collection
Anticipated
Actual
11/07/2016
Sample size
Target
86
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6552 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 14150 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 294403 0
Hospital
Name [1] 294403 0
The Prince Charles Hospital
Country [1] 294403 0
Australia
Primary sponsor type
Individual
Name
Usha Gurunathan
Address
The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country
Australia
Secondary sponsor category [1] 293251 0
None
Name [1] 293251 0
None
Address [1] 293251 0
Nil
Country [1] 293251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295824 0
The Prince Charles HREC
Ethics committee address [1] 295824 0
Ethics committee country [1] 295824 0
Australia
Date submitted for ethics approval [1] 295824 0
Approval date [1] 295824 0
20/12/2013
Ethics approval number [1] 295824 0
HREC/13/QPCH/335

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

Contacts
Principal investigator
Name 68618 0
Dr Usha Gurunathan
Address 68618 0
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country 68618 0
Australia
Phone 68618 0
+61 7 3139 4000
Fax 68618 0
Email 68618 0
[email protected]
Contact person for public queries
Name 68619 0
Usha Gurunathan
Address 68619 0
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD- 4032
Country 68619 0
Australia
Phone 68619 0
+61 7 3139 4000
Fax 68619 0
Email 68619 0
[email protected]
Contact person for scientific queries
Name 68620 0
Usha Gurunathan
Address 68620 0
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, QLD- 4032
Country 68620 0
Australia
Phone 68620 0
+61 7 3139 4000
Fax 68620 0
Email 68620 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseUsefulness of a visual aid in achieving optimal positioning for spinal anesthesia: A randomized trial.2018https://dx.doi.org/10.1186/s12871-017-0467-3
N.B. These documents automatically identified may not have been verified by the study sponsor.