Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000893606
Ethics application status
Approved
Date submitted
10/08/2014
Date registered
22/08/2014
Date last updated
22/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Transient hip and knee flexion for rapid onset spinal anaesthesia (ROSA) for caesarean section, a randomised control study
Scientific title
Transient hip and knee flexion for rapid onset spinal anaesthesia (ROSA) for women undergoing elective caesarean section, a randomised control study to evaluate the time from completing spinal injection until the anaesthetist determines surgery can proceed and surgery commences.
Secondary ID [1] 285116 0
nil
Universal Trial Number (UTN)
Trial acronym
ROSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia for women undergoing elective caesarean section with a target intervention of reducing time to starting caesarean section. 292674 0
Condition category
Condition code
Anaesthesiology 292985 292985 0 0
Anaesthetics
Reproductive Health and Childbirth 293048 293048 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediately after finishing intrathecal injection, patients in the control group will be laid supine with a 10-15 degree tilt to the left and their lower limbs straight. The drug and dose of intrathecal injection will remain the choice of the anaesthetist and will not be controlled in this study.

Patients in the intervention group will be laid supine with a 10-15 degree tilt to the left and their lower limbs flexed at the hips and knees maintained for 45 seconds before straightening them as per the control group.

Note that if patient cannot tolerate the positioning, the manoeuvre is to be discontinued immediately and anaesthesia positioning will be continued with the patient's lower limbs straight as per the control group.

Measurement and documentation of the block height will take place every 3 minutes post intrathecal injection using ice to test cold sensation in the anterior axillary line
Intervention code [1] 289965 0
Treatment: Other
Comparator / control treatment
Immediately after finishing intrathecal injection, patients in the control group will be laid supine with a 10-15 degree tilt to left and their lower limbs straight.

The drug and dose of intrathecal injection will remain the choice of the anaesthetist and will not be controlled in this study.
Control group
Active

Outcomes
Primary outcome [1] 292846 0
The time from completing spinal injection until the anaesthetist determines surgery can proceed
Timepoint [1] 292846 0
The time from completing spinal injection until the anaesthetist determines surgery can proceed
Primary outcome [2] 292921 0
The time from completing spinal injection until surgery commences.
Timepoint [2] 292921 0
The time from completing spinal injection until surgery commences.
Secondary outcome [1] 309794 0
Number of women requiring treatment for hypotension
Timepoint [1] 309794 0
Prior to conclusion of surgery
Secondary outcome [2] 309941 0
Number of women with high block requiring treatment
Timepoint [2] 309941 0
Prior to conclusion of surgery
Secondary outcome [3] 309942 0
Number of women not tolerating the position after anaesthesia
Timepoint [3] 309942 0
Prior to conclusion of surgery
Secondary outcome [4] 309943 0
Number of women dissatisfied with the positioning
Timepoint [4] 309943 0
Before the 60 seconds are completed to lie supine with left lateral tilt (asking women verbally)
Secondary outcome [5] 309944 0
Number of women requiring general anaesthesia
Timepoint [5] 309944 0
Prior to conclusion of surgery
Secondary outcome [6] 309945 0
Number of babies with an APGAR <7.
Timepoint [6] 309945 0
At 1 minute and 5 minutes of life
Secondary outcome [7] 309946 0
Neonatal intubation
Timepoint [7] 309946 0
Before 20 minutes of life

Eligibility
Key inclusion criteria
Parturients having elective lower segment caesarean section under spinal anaesthesia

>18 years
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women <18 years old

Women requiring an interpreter when one is unavailable

Women with an intellectual or mental impairment

Women with pre-existing medical, rheumatologic or orthopaedic conditions which prevents them from performing the manoeuvre correctly e.g. recent lower limb fracture, ankylosing spondylitis.

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)
Participants will be recruited during the routine pre-operative anaesthetic consult prior to caesarean section by a researcher.

During this consult careful explanation of the study aims and procedure as well as risks and benefits will occur.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will be using computer-generated random numbers for randomisation of the patients into intervention or control groups. Allocation concealment will be achieved by using consecutively numbered opaque sealed envelopes containing the randomised sequence opened only after the patient is in the operating theatre with all consents signed and baseline data collected.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2808 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 8515 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 289723 0
Hospital
Name [1] 289723 0
Women's and Children's Hospital
Country [1] 289723 0
Australia
Primary sponsor type
Individual
Name
Dr. Allan Cyna
Address
Women's and Children's Hospital
72 King William St. North Adelaide, SA 5006
Country
Australia
Secondary sponsor category [1] 288468 0
Hospital
Name [1] 288468 0
Women's and Children's Hospital
Address [1] 288468 0
72 King William St. North Adelaide
South Australia, 5006
Australia
Country [1] 288468 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291477 0
Women's and Children's Hospital
Ethics committee address [1] 291477 0
72 King William St. North Adelaide
South Australia, 5006
Australia
Ethics committee country [1] 291477 0
Australia
Date submitted for ethics approval [1] 291477 0
Approval date [1] 291477 0
09/07/2014
Ethics approval number [1] 291477 0

Summary
Brief summary
The aim of this study is to assess whether, following a spinal anaesthetic for caesarean, transient maternal hip and knee flexion in the left lateral tilt supine position can allow caesarean section to commence earlier than traditional positioning with lower limbs straight.
If this technique safely speeds up the onset of "adequate" surgical block suitable for the caesarean operation, it can potentially reduce the rate of caesarean sections requiring general anaesthetics. It is well established that in pregnant women requiring caesarean section most of the anaesthesia related risks have higher rate under general anaesthesia in comparison to spinal anaesthesia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50506 0
Dr Allan Cyna
Address 50506 0
Women's and Children's Hospital
72 King William St. North Adelaide
South Australia, 5006
Australia
Country 50506 0
Australia
Phone 50506 0
61405725060
Fax 50506 0
Email 50506 0
allan.cyna@health.sa.gov.au
Contact person for public queries
Name 50507 0
Dr Brigid Brown
Address 50507 0
Women's and Children's Hospital
72 King William St. North Adelaide
South Australia, 5006
Australia
Country 50507 0
Australia
Phone 50507 0
61405725060
Fax 50507 0
Email 50507 0
brigid.brown@gmail.com
Contact person for scientific queries
Name 50508 0
Dr Chelsea Hicks
Address 50508 0
Women's and Children's Hospital
72 King William St. North Adelaide
South Australia, 5006
Australia
Country 50508 0
Australia
Phone 50508 0
61405725060
Fax 50508 0
Email 50508 0
chelsea.hicks2@health.sa.gov.au

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
No additional documents have been identified.