Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000842864
Ethics application status
Approved
Date submitted
9/08/2012
Date registered
10/08/2012
Date last updated
16/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block, with and without adrenaline, for gynaecologic surgery
Scientific title
Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block, with and without adrenaline, for gynaecologic surgery
Secondary ID [1] 281000 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block, with and without adrenaline added. 287135 0
Condition category
Condition code
Anaesthesiology 287456 287456 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound-guided transversus abdominis plane block using ropivacine 0.2% (3mg/kg) with adrenaline 1:400,000 added, for postoperative analgesia after gynaecologic surgery
Intervention code [1] 285458 0
Treatment: Drugs
Comparator / control treatment
Ultrasound-guided transversus abdominis plane block using ropivacine 0.2% (3mg/kg) without any adrenaline added, for postoperative analgesia after gynaecologic surgery
Control group
Active

Outcomes
Primary outcome [1] 287719 0
Plasma ropivacaine concentration
Timepoint [1] 287719 0
10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after completion of the block injections.
Secondary outcome [1] 298702 0
Nil
Timepoint [1] 298702 0
Nil

Eligibility
Key inclusion criteria
Female patients more than 18 years of age undergoing elective gynaecological surgery and who are planned to receive transversus abdominis plane blocks will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have any allergy/sensitivity to local anaesthetic, infection at the site of block placement, pre-existing neurologic or muscular disease, bleeding tendency or evidence of coagulopathy, significant renal or liver dysfunction, or are pregnant.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2012
Actual
10/09/2012
Date of last participant enrolment
Anticipated
Actual
18/03/2013
Date of last data collection
Anticipated
Actual
20/03/2013
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285787 0
Hospital
Name [1] 285787 0
Royal Prince Alfred Hospital
Country [1] 285787 0
Australia
Primary sponsor type
Individual
Name
A/Prof John Loadsman
Address
Anaesthetics
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW
2050
Country
Australia
Secondary sponsor category [1] 284610 0
None
Name [1] 284610 0
Address [1] 284610 0
Country [1] 284610 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287795 0
Ethics Review Committee, Royal Prince Alfred Hospital
Ethics committee address [1] 287795 0
Ethics committee country [1] 287795 0
Australia
Date submitted for ethics approval [1] 287795 0
10/04/2012
Approval date [1] 287795 0
05/07/2012
Ethics approval number [1] 287795 0
X12-0115 & HREC/12/RPAH/197

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34557 0
A/Prof John Loadsman
Address 34557 0
Dept of Anaesthetics Royal Prince Alfred Hospital Missenden Rd Camperdown NSW 2050
Country 34557 0
Australia
Phone 34557 0
+61 2 95156111
Fax 34557 0
+61 2 95192455
Email 34557 0
http://anaes.med.usyd.edu.au/mail/messagejl.html
Contact person for public queries
Name 17804 0
John Loadsman
Address 17804 0
Dept of Anaesthetics
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 17804 0
Australia
Phone 17804 0
+61 2 95156111
Fax 17804 0
+61 2 95192455
Email 17804 0
http://anaes.med.usyd.edu.au/mail/messagejl.html
Contact person for scientific queries
Name 8732 0
John Loadsman
Address 8732 0
Dept of Anaesthetics
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 8732 0
Australia
Phone 8732 0
+61 2 95156111
Fax 8732 0
+61 2 95192455
Email 8732 0
http://anaes.med.usyd.edu.au/mail/messagejl.html

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.