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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
Gender
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
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)
NSW

Funding & Sponsors
Funding source category [1] 285787 0
Hospital
Name [1] 285787 0
Royal Prince Alfred Hospital
Address [1] 285787 0
Missenden Rd
Camperdown NSW
2050
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
Research Development Office
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
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
This study will investigate the effect of including a small amount of adrenaline in the local anaesthetic (ropivacaine) solution used for the abdominal wall nerve blocks commonly performed now to provide pain relief after abdominal surgery. Ropivacaine is commonly used for these nerve blocks because it is a longer-acting local anaesthetic. Adrenaline is a naturally occurring substance in the human body. It is commonly added to local anaesthetics to increase the duration of their effect, and to reduce the rate local anaesthetic is taken up into the blood stream (to limit the risk of side effects to the local anaesthetic). The specific purpose of this study is to determine how much, if at all, the inclusion of adrenaline reduces uptake of the local anaesthetic ropivacaine, with these particular blocks, and thus whether or not it increases the safety. Currently, adrenaline is routinely added to local anaesthesics for certain types of nerve blocks but its potential safety benefit in abdominal wall blocks using ropivacaine is unclear.
Trial website
Trial related presentations / publications
Loadsman J, Chan R, Pather S, Kam P. Plasma Ropivacaine Concentrations after Ultrasound-Guided Transversus Abdominis Plane Block, With and Without Adrenaline, for Gynaecologic Surgery. Australian Society of Anaesthetists National Scientific Congress, Canberra, Australian Capital Territory, Australia. September 2013.
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
A/Prof 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
A/Prof 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
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