Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000228088
Ethics application status
Approved
Date submitted
15/03/2010
Date registered
18/03/2010
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pre-Epidural Rapid Ultrasound Assessment of landmarks, Observational Study
Scientific title
In Obese Parturients, is a pre-epidural ultrasound better than clinical assessment for the placement of a neuraxial block.
Secondary ID [1] 1507 0
None
Universal Trial Number (UTN)
U1111-1114-4719
Trial acronym
PERUSAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Placement of Neuraxial blockade in obese parturients 256973 0
Condition category
Condition code
Anaesthesiology 257117 257117 0 0
Pain management
Reproductive Health and Childbirth 257141 257141 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Immediately prior to the insertion of the epidural, three ultrasound views of the lumbar bony anatomy will be performed. 1) Finding the superior aspect of the iliac crests, 2) Finding the midline of the lumbar spine 3) Finding the level of an appropriate ligamentum flavum to target for the insertion of the epidural.
This information is combined to give both the site for the needle insertion and the direction to advance the needle.
The study is planned to be completed in less than 12 months.
Intervention code [1] 256150 0
Not applicable
Comparator / control treatment
The traditional clinical tecnique of palpation of the lumbar anatomy. This envolves 1) palpating for the iliac crest. 2) palpating to feel the spinous processes and hence mdline of the lumbar spine. 3) Palpating to feel the interspinous space.
This information is combined to give the point fo insertion and the anaesthetist guesses the direction to advance the needle from previous clinical experience.
Control group
Active

Outcomes
Primary outcome [1] 258012 0
The number of forward passes of the epidural Tuohy needle to correctly enter the epidural space.
Timepoint [1] 258012 0
At time of epidural insertion
Secondary outcome [1] 263576 0
Time to perform pre-epidural ultrasound
Timepoint [1] 263576 0
At time of epidural insertion
Secondary outcome [2] 263577 0
Time with Epidural needle in-situ
Timepoint [2] 263577 0
At time of epidural insertion

Eligibility
Key inclusion criteria
Pregnant, Body Mass Index greater than 35, for elective caesarean section or labour ward analgesia.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non english speaking
Unable to gain informed consent due to pain.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
24/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256655 0
Charities/Societies/Foundations
Name [1] 256655 0
Australian Society of Anaesthetist
Country [1] 256655 0
Australia
Primary sponsor type
Individual
Name
Dr Christopher Hugh Mitchell
Address
Anaesthetic Department
King Edward Memorial Department
374 Bagot Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 255943 0
None
Name [1] 255943 0
Address [1] 255943 0
Country [1] 255943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258677 0
King Edward Memorial Hospital ethics committee of the Women and Newborn Health Service
Ethics committee address [1] 258677 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco
WA 6008
Ethics committee country [1] 258677 0
Australia
Date submitted for ethics approval [1] 258677 0
Approval date [1] 258677 0
05/02/2010
Ethics approval number [1] 258677 0
1771/EW

Summary
Brief summary
Ultrasound assessment of the lumbar region prior to neuraxial blockade is becoming more popular. Trials have demonstrated a smalll benefit in thin patients. It is hypothesised that a bigger benefit will be found in obese patients in whom it is difficult to determine lumbar anatomy by traditional palpatio techniques.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30940 0
Address 30940 0
Country 30940 0
Phone 30940 0
Fax 30940 0
Email 30940 0
Contact person for public queries
Name 14187 0
Dr Chris Mitchell
Address 14187 0
Anaesthetic Department
King Edward Memorial Department
374 Bagot Rd
Subiaco WA 6008
Country 14187 0
Australia
Phone 14187 0
+61 8 9340 2222
Fax 14187 0
Email 14187 0
mitchwa@gmail.com
Contact person for scientific queries
Name 5115 0
Dr Chris Mitchell
Address 5115 0
Anaesthetic Department
King Edward Memorial Department
374 Bagot Rd
Subiaco WA 6008
Country 5115 0
Australia
Phone 5115 0
+61 8 9340 2222
Fax 5115 0
Email 5115 0
mitchwa@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
No additional documents have been identified.