Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000389404
Ethics application status
Not yet submitted
Date submitted
12/07/2007
Date registered
24/07/2007
Date last updated
24/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of ultrasound guided Transversus Abdominis Plane (TAP) block following major abdominal surgery: a randomised controlled trial.
Scientific title
women undergo elective caesarean section-Transversus Abdominis Plane (TAP) block on the abdominal wall under ultrasound guidance-conventional postoperative analgesic management-reduce pain medications post operation and improve patient comfort
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy women undergo elective caesarean section, no allergy to the analgesic drug ropivacaine and morphine. 1971 0
Condition category
Condition code
Reproductive Health and Childbirth 2069 2069 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Intervention: patient receive ropivacaine 200mg by the TAP block technique.
All patients will be treated with standardised pain management and post analgesic care after surgery including a Patient Controlled Analgesia (PCA) device which will deliver standard doses of morphine (1mg with a 5 minute lockout) intravenously when patient requires it for pain relief.
Intervention code [1] 1849 0
Treatment: Other
Comparator / control treatment
Control: patients receive injection of normal saline by the TAP block technique.
Control group
Placebo

Outcomes
Primary outcome [1] 3159 0
Morphine requirement by patient
Timepoint [1] 3159 0
At 24 hours, 48 hours and 5-days period.
Secondary outcome [1] 4899 0
Other pain medications and patient satisfaction
Timepoint [1] 4899 0
At 24h, 48h and 5-days period.

Eligibility
Key inclusion criteria
Women undergo elective caesarean section
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency caesarean section, refusal to participate in the study, allergies to any of the drugs used in the study (e.g. morphine or ropivacaine); insufficiency in speaking or reading English.

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)
Randomisation slips will be stored in numbered opaque sealed envelopes and opened only in consented patients prior to surgery
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be computer generated in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients will be blinded from what injection they receive. Only the anaesthetist who performed the procedure knows what the patient received, others including an observer will be blinded and responsible for monitoring patient’s progress and pain treatment requirements. The data analyst will also be blinded.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2215 0
Hospital
Name [1] 2215 0
Department of Anaesthesia, St Vincent's Hospital
Country [1] 2215 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St Vincent's Hospital
Address
Country
Australia
Secondary sponsor category [1] 1998 0
Individual
Name [1] 1998 0
Dr Michael Barrington, St Vincent's Hospital
Address [1] 1998 0
Country [1] 1998 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4052 0
St Vincent's Hospital
Ethics committee address [1] 4052 0
Ethics committee country [1] 4052 0
Australia
Date submitted for ethics approval [1] 4052 0
Approval date [1] 4052 0
Ethics approval number [1] 4052 0

Summary
Brief summary
The object of this project is to determine how useful an ultrasound guided TAP block is in reducing requirement for pain medications following elective caesarean section.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27663 0
Address 27663 0
Country 27663 0
Phone 27663 0
Fax 27663 0
Email 27663 0
Contact person for public queries
Name 11038 0
Dr Michael Barrington
Address 11038 0
c/o Department of Anaesthesia
St Vincent’s Hospital
Melbourne Fitzroy VIC 3065
Country 11038 0
Australia
Phone 11038 0
92882211, 92884257
Fax 11038 0
92884255
Email 11038 0
[email protected]
Contact person for scientific queries
Name 1966 0
Dr Michael Barrington
Address 1966 0
c/o Department of Anaesthesia
St Vincent’s Hospital
Melbourne Fitzroy VIC 3065
Country 1966 0
Australia
Phone 1966 0
92882211, 92884257
Fax 1966 0
92884255
Email 1966 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.