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Trial registered on ANZCTR


Registration number
ACTRN12611001201965
Ethics application status
Approved
Date submitted
21/11/2011
Date registered
22/11/2011
Date last updated
22/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to define the pharmacokinetic properties of lignocaine gel applied topically on a surgical field
Scientific title
A study to define the pharmacokinetic properties of lignocaine gel applied topically on a surgical field for females sheduled to undergo gynaecological surgery involving either laparoscopy or hysteroscopy
Secondary ID [1] 273420 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effects of lignocaine on surgical wounds in laparoscopy or hysteroscopy 279209 0
Condition category
Condition code
Anaesthesiology 279415 279415 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine if reconstituted lignocaine at 4.8% with buffer , applied as a 6 ml gel (named Pluscaine) onto a surgical field once only, does absorb into the blood stream and, if so, to what extent. This intervention was applied at the end of the surgical intervention taking about 5 minutes.
Intervention code [1] 283756 0
Treatment: Drugs
Comparator / control treatment
The studed medication was applied on two groups patients: 1) laparoscopic surgery, 2) hysteroscopy. There is no control groups. There is no planned comparison as such between groups.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 285985 0
To determine if lignocaine, applied as a gel onto a surgical field, does absorb into the blood stream and, if so, to what extent by blood samples collected at time of induction of anaesthesia (time 0) and at the following times (+ 10%) after application of Pluscaine?: 0.25h, 0.5h, 0.75h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, and 24.0h.
Timepoint [1] 285985 0
The Pluscaine(study medication) will be applied at the end of the surgical intervention
Secondary outcome [1] 294898 0
To define the Cmax (maximum concentration in serum), Tmax (time at which the maximum concentration occurs) and area under the concentration curve (AUC) of 6mLs of Pluscaine
Timepoint [1] 294898 0
Blood samples will be collected at time of induction of anaesthesia (time 0) and at the following times (+ 10%) after application of Pluscaine: 0.25h, 0.5h, 0.75h, 1.0h, 1.5h, 2.0h, 3.0h, 4.0h, 6.0h, and 24.0h.

Eligibility
Key inclusion criteria
female aged 18 to 80
Scheduled to undergo gynaecological surgery, involving either laparoscopy or hysteroscopy
Anaesthesia risk category level I and II
Minimum age
18 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Renal or hepatic impairment on history, general clinical examination or in medical record
Medical or other condition(s) (including heart failure) placing candidate in anaesthesia risk category level III or higher
Known allergy to lignocaine

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consent will be obtained after the study has been explained and the woman understands the nature of the study and her involvement. Twelve patients will be recruited from the outpatient clinics at the Royal Hospital for Women. Six of these patients will be scheduled to undergo laparoscopic surgery . Six other patients will be scheduled to undergo surgery on the uterus, which involves wounds of the inner cavity of the organ.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 1
Type of endpoint(s)
Safety
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] 284234 0
Commercial sector/Industry
Name [1] 284234 0
Medortus Inc
Address [1] 284234 0
332 Burns Bay Road
Lane Cove NSW 2066
Country [1] 284234 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medortus Inc
Address
332 Burns Bay Road
Lane Cove NSW 2066
Country
Australia
Secondary sponsor category [1] 269190 0
Hospital
Name [1] 269190 0
Barbara Gross Research Unit
Address [1] 269190 0
Level 0, Royal Hospital for Women,
Barker St
Randwick 2031
Country [1] 269190 0
Australia
Other collaborator category [1] 260357 0
Hospital
Name [1] 260357 0
Barbara Gross Research Unit
Address [1] 260357 0
Level 0, Royal Hospital for Women,
Barker St
Randwick 2031
Country [1] 260357 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286198 0
South Eastern Sydney & Illawarra Area Health Service-HERC
Ethics committee address [1] 286198 0
Prince Wales Hospital
Randwick 2031 NSW
Ethics committee country [1] 286198 0
Australia
Date submitted for ethics approval [1] 286198 0
27/04/2009
Approval date [1] 286198 0
28/10/2009
Ethics approval number [1] 286198 0
HREC 09/062

Summary
Brief summary
The aim of this study is to determine if an anaesthetic product applied as a gel onto a surgical field does absorb into the blood stream and, if so, to what extent. It is important to have this information because anaesthetic products can become toxic at a certain concentration.
Twelve women who will undergo surgery at the Royal Hospital for Women (RHW) will be recruited for this study. Six among them will have laparoscopic surgery involving the abdominal wall and the pelvic organs; the other six will
have surgery involving the uterus. Women will be approached at the public clinics of the RHW. Women will be
given written and verbal information regarding the study at least a week prior to undergoing the surgery.
The consented subjects will have the anaesthetic gel applied to the surgical wounds at the end of their procedure. Blood samples will be taken once before and ten times after the application of gel. The timing of the sampling will be spread over a period of 24 hours. All samples will be kept in a freezer until the end of the study and sent to a
specialised laboratory for measurement of the concentration of anaesthetic product in the blood. The subjects will be monitored with regard to blood pressure, pulse and other vital signs as per normal hospital protocol and discharged from the study 24hours after their surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33415 0
Address 33415 0
Country 33415 0
Phone 33415 0
Fax 33415 0
Email 33415 0
Contact person for public queries
Name 16662 0
Thierry Vancaillie
Address 16662 0
Director, Women's Health and Research Institute of Australia
Royal Hospital for Women, Level 2, Barker St,
Randwick NSW 2031,
Country 16662 0
Australia
Phone 16662 0
0061 2 9382 6621
Fax 16662 0
0061 2 9382 6660
Email 16662 0
thierryvancaillie@mac.com
Contact person for scientific queries
Name 7590 0
Thierry Vancaillie
Address 7590 0
Director, Women's Health and Research Institute of Australia
Royal Hospital for Women, Level 2, Barker St,
Randwick NSW 2031
Country 7590 0
Australia
Phone 7590 0
0061 2 9382 6621
Fax 7590 0
0061 2 9382 6660
Email 7590 0
thierryvancaillie@mac.com

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