Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000549820
Ethics application status
Approved
Date submitted
16/05/2012
Date registered
23/05/2012
Date last updated
23/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of needle visibility during insertion of ultrasound guided transversus abdominis plane (TAP) blocks for women undergoing lower abdominal surgery.
Scientific title
In women receiving ultrasound guided transversus abdominis plane blocks for gynaecological or obstetric surgery is there a difference in the needle tip visibility when an echogenic needle is used compared to a non-echogenic needle.
Secondary ID [1] 280500 0
Nil
Universal Trial Number (UTN)
Trial acronym
The SEETAP Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief after gynaecological or obstetric surgery. 286478 0
Condition category
Condition code
Anaesthesiology 286736 286736 0 0
Pain management
Reproductive Health and Childbirth 286807 286807 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All groups will undergo surgery under general anaesthesia. The anaesthetic technique will not be stipulated. At the end of surgery, whilst the patient is still asleep, bilateral TAP blocks will be inserted by the anaesthetist in theatre. Using an echogenic needle for one side and a non-echogenic needle for the other side. Real-time ultrasound guidance will be used to site the needle tip below the fascia with the TAP. Which needle is used first will be determined by the randomisation process. The time taken to perform the TAP block on each side will be recorded from the time the needle goes through the skin until the time the injection of local anaesthetic is complete. The dose of local anaesthetic used will be 1.5mg/kg of ropivacaine diluted to a total volume of 20ml used each side. The maximal total dose will be 200mg ropivacaine. A 60 sec retrospective video clip of the ultrasound image will be recorded once 10mls of local anaesthetic has been injected.
Intervention code [1] 284865 0
Treatment: Devices
Comparator / control treatment
Non-echogenic needle
Control group
Active

Outcomes
Primary outcome [1] 287132 0
Needle tip visibility (total time needle tip in view from 60sec video clip taken prior to injection)
Timepoint [1] 287132 0
During 60 second video clip taken with ultrasound.
Secondary outcome [1] 297454 0
Time taken to perform block (from the needle through skin to 10ml of local anaesthetic deposited)
Timepoint [1] 297454 0
From time needle is through skin to injection of 10ml of local anaesthetic.
Secondary outcome [2] 297455 0
Sensory block to ice
Timepoint [2] 297455 0
checked in recovery 30 mins after block performed.
Secondary outcome [3] 297456 0
Anaesthetist difficulty of insertion rating. Following bilateral TAP block insertion the anaesthetist will be asked to rate the difficulty of insertion on side one and side two using a five point scale.
1 Very Easy
2 Easy
3 Moderate
4 Some Difficulty
5 Very Difficult
Timepoint [3] 297456 0
After block inserted.
Secondary outcome [4] 297457 0
Needle visibility rating
Timepoint [4] 297457 0
best view of needle from 60sec video clip rated on a 5 point scale

Eligibility
Key inclusion criteria
ASA 1 to 3
Elective or Non-elective abdominal gynaecological or obstetric surgery for which a TAP block will be used.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal or withdrawal of consent at any stage
Anaphylaxis or hypersensitivity to local anaesthetics
Non-English speaking

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)
Women will be recruited either at pre-admission clinics or pre-operatively in the day-surgical unit or hospital wards. All will be American Society of Anesthesiologists (ASA) Class 1 to 3 and scheduled for general anaesthesia and TAP blocks.
Patients will be randomised preoperatively into one of two groups based on a computer-derived randomisation sequence using opaque sealed envelopes.
Two separate randomisation sequences will be used for patients above or below a BMI of 30.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised preoperatively into one of two groups based on a computer-derived randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285257 0
Self funded/Unfunded
Name [1] 285257 0
Country [1] 285257 0
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital for Women.
Address
King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008.
Country
Australia
Secondary sponsor category [1] 284119 0
None
Name [1] 284119 0
Address [1] 284119 0
Country [1] 284119 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287274 0
King Edward Memorial Hospital for Women Ethics Committee, Women and Newborn Health Service.
Ethics committee address [1] 287274 0
King Edward Memorial Hospital for Women, GPO Box D184, Perth, WA 6840.
Ethics committee country [1] 287274 0
Australia
Date submitted for ethics approval [1] 287274 0
Approval date [1] 287274 0
04/05/2012
Ethics approval number [1] 287274 0
2000/EW

Summary
Brief summary
This trial is investigating whether echogenic needle technology improves needle visibility and ease of insertion when transversus abdominus plane (TAP) blocks are used for gynaecological and obstetric operations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34184 0
Address 34184 0
Country 34184 0
Phone 34184 0
Fax 34184 0
Email 34184 0
Contact person for public queries
Name 17431 0
Melanie Bloor
Address 17431 0
Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008.
Country 17431 0
Australia
Phone 17431 0
+61 8 93402222
Fax 17431 0
+61 8 93402260
Email 17431 0
[email protected]
Contact person for scientific queries
Name 8359 0
Melanie Bloor
Address 8359 0
Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, WA 6008.
Country 8359 0
Australia
Phone 8359 0
+61 8 93402222
Fax 8359 0
+61 8 93402260
Email 8359 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
No additional documents have been identified.