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Trial registered on ANZCTR


Registration number
ACTRN12608000161325
Ethics application status
Approved
Date submitted
25/03/2008
Date registered
3/04/2008
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound Guided Transversus Abdominis Plane Block in Major Gynaecological Surgery – A randomised controlled Trial
Scientific title
A randomised placebo-controlled double-blind trial assessing the analgesic efficacy of ultrasound guided transversus abdominis plane local anaesthetic block in major gyanae-oncological surgery
Secondary ID [1] 288001 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative Pain 2955 0
Condition category
Condition code
Anaesthesiology 3095 3095 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound guided transversus abdominis plane (TAP) local anaesthetic blockade. This involves two injections of 20ml 0.5% ropivicaine (total 40ml). The injections take around 10 minutes to perform.
Intervention code [1] 2725 0
Treatment: Drugs
Comparator / control treatment
ultrasound guided TAP blockade with normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 3983 0
Pain Score (Visual Analogue Scale) > 50mm with forced expiration
Timepoint [1] 3983 0
2 hours post-intervention
Secondary outcome [1] 6701 0
VAS >50mm with forced expiration
Timepoint [1] 6701 0
24 hours post-intervention
Secondary outcome [2] 6702 0
Total Morphine Consumption
Timepoint [2] 6702 0
2 and 24 hours post-intervention

Eligibility
Key inclusion criteria
Adult females scheduled to undergo laparotomy via midline incision for known or suspected gynae-oncology
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
inability/unwillingness to provide informed consent, allergy/sensitivity to any of the protocol medications, patient or treating anaesthetist preference to use epidural (or other) analgesia

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)
A randomisation table will allocate the 70 patients in the study to either treatment or placebo. The hospital pharmacy will make up syringes containing either local anaesthetic or placebo in accordance with the randomisation table. They will then be labelled with Study Patient 1, Study Patient 2, etc. but not the contents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number table will be used for sequence generation (eg. www.random.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 3212 0
Hospital
Name [1] 3212 0
Department of Anaesthesia, Royal Women's Hospital
Address [1] 3212 0
Grattan St
Carlton Vic. 3053
Country [1] 3212 0
Australia
Primary sponsor type
Individual
Name
James Griffiths
Address
Department of Anaesthesia
Royal Women's Hospital
Grattan St
Carlton Vic. 3053
Country
Australia
Secondary sponsor category [1] 2880 0
Hospital
Name [1] 2880 0
Department of Anaesthesia, Royal Women's Hospital
Address [1] 2880 0
Grattan St
Carlton Vic. 3053
Country [1] 2880 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5196 0
Royal Women's Hospital Research and Ethics Committee
Ethics committee address [1] 5196 0
Grattan St,
Parkville Vic 3052
Ethics committee country [1] 5196 0
Australia
Date submitted for ethics approval [1] 5196 0
07/05/2008
Approval date [1] 5196 0
01/11/2008
Ethics approval number [1] 5196 0

Summary
Brief summary
The project aims to demonstrate that transversus abdominis plane block is an effective adjunct to multi-modal analgesia in the setting of major gynaecological surgery via midline laparotomy. The project aims to demonstrate that the technique improves overall pain relief, reduces morphine consumption (and opioid side effects) and improves patient satisfaction.
Trial website
Trial related presentations / publications
Griffiths JD, Middle J, Barron F, Grant S, Popham P, Royse C. Transversus abdominis plane block does not provide additional benefit to multimodal analgesia in gynaecological cancer surgery. Anaesth Analg, 111(3): 797-801 (2010)
Public notes

Contacts
Principal investigator
Name 28459 0
Dr James Griffiths
Address 28459 0
Department of Anaesthesia
Royal Women's Hospital
Grattan St
PARKVILLE Vic 3052
Country 28459 0
Australia
Phone 28459 0
+61383452381
Fax 28459 0
Email 28459 0
james.griffiths@thewomens.org.au
Contact person for public queries
Name 11616 0
Dr Dr James Griffiths
Address 11616 0
Royal Women's Hospital
Grattan St
Carlton Vic. 3053
Country 11616 0
Australia
Phone 11616 0
+614 18306793
Fax 11616 0
+613 94971739
Email 11616 0
james.griffiths@rwh.org.au
Contact person for scientific queries
Name 2544 0
Dr Dr James Griffiths
Address 2544 0
Royal Women's Hospital
Grattan St
Carlton Vic. 3053
Country 2544 0
Australia
Phone 2544 0
+61383452381
Fax 2544 0
+61383452379
Email 2544 0
james.griffiths@rwh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary