Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000104853
Ethics application status
Approved
Date submitted
18/01/2012
Date registered
23/01/2012
Date last updated
25/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Total and free serum Ropivacaine Concentrations for patients receiving Continuous Transversus Abdominis plane block for Postoperative analgesia after abdominal surgery: Pilot Study
Scientific title
Total and free serum Ropivacaine Concentrations for patients receiving Continuous Transversus Abdominis plane block for Postoperative analgesia after abdominal surgery: Pilot Study
Secondary ID [1] 279767 0
none
Universal Trial Number (UTN)
Trial acronym
ROP- CON study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Local anaestetic concentration after a bolus followed by continuous infusion in TAP block 279252 0
Condition category
Condition code
Anaesthesiology 279453 279453 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients having mid line incision will have TAP block catheter towards the end of surgery. They will recieve 20 mls of 0.5% ropivacaine Bilateral (both sides) followed by continous infusion of 10mls/hr of 0.2% ropivacaine for 48hrs which will be started 30mins post 2nd bolus.
Intervention code [1] 283782 0
Treatment: Drugs
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286015 0
Total and free ropivacaine concentration will be analysed using High Performance Liquid Chromatograph(HPLC).
Timepoint [1] 286015 0
predose, 15 mins post 2nd bolus, 30 mins, 45 mins, 60 mins, 2hr, 4hr, 8hr, 12hr,24 hr, 48 hr
Secondary outcome [1] 294980 0
Serial ECG's will be done to monitor any arrhythmia & to measure QTc interval as a prolonged QT interval is a biomarker for ventricular tachyarrhythmias.
Timepoint [1] 294980 0
pre op, 6hrs post 2nd bolus, 12hrs, 24 hrs, 48hrs
Secondary outcome [2] 294983 0
patients will be observed for sign & symptoms of Local anesthetic toxicity in terms of: BP, HR & rhythum, peri oral / tongue numbness, any visual changes, muscle twitching, convulsions
Timepoint [2] 294983 0
15mins( 2nd bolus), 30mins, 45 mins, 60 mins, 2 hrs, 4hr, 8 hr, 12hr, 24hr & 48hr

Eligibility
Key inclusion criteria
Elective/Emergency abdominal surgery
Between 18 and 80 years of age
ASA less than 4
Adequate English language skills
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Allergy to local anaesthetic
2 Pt refusal
3 ASA score > 4 (i.e 4,5)
4 Pregnancy
5 On regular opioid medication or any other medication for
chronic pain management.
6 Mental handicap or psychiatric condition precluding adequat
communication.
7 Patients taking ciprofloxacin & fluvoxamine (affects
the metabolism of LA)
8 Qt c interval > 0.45 sec in males and > 0.47 sec in females
9 Drugs affecting Qtc interval e.g. Haloperidol, Amiodarone,
Sotaol

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284552 0
Self funded/Unfunded
Name [1] 284552 0
Country [1] 284552 0
Primary sponsor type
Individual
Name
Dr Sarika Kumar
Address
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA
5011
Country
Australia
Secondary sponsor category [1] 269212 0
Individual
Name [1] 269212 0
Dr Vasanth Rao
Address [1] 269212 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA
5011
Country [1] 269212 0
Australia
Secondary sponsor category [2] 269213 0
Individual
Name [2] 269213 0
Dr Richard Watts
Address [2] 269213 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA
5011
Country [2] 269213 0
Australia
Secondary sponsor category [3] 283475 0
None
Name [3] 283475 0
Address [3] 283475 0
Country [3] 283475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286221 0
Humen Research Ethics Committee
Ethics committee address [1] 286221 0
Ethics committee country [1] 286221 0
Australia
Date submitted for ethics approval [1] 286221 0
Approval date [1] 286221 0
24/09/2011
Ethics approval number [1] 286221 0
2011063

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

Contacts
Principal investigator
Name 33435 0
Address 33435 0
Country 33435 0
Phone 33435 0
Fax 33435 0
Email 33435 0
Contact person for public queries
Name 16682 0
Dr Sarika Kumar
Address 16682 0
28 Woodville Road,
Woodville South, SA 5011
Country 16682 0
Australia
Phone 16682 0
+61421916106
Fax 16682 0
Email 16682 0
libransarika@yahoo.com
Contact person for scientific queries
Name 7610 0
Dr Vasanth Rao
Address 7610 0
28 Woodville Road,
Woodville South, SA 5011
Country 7610 0
Australia
Phone 7610 0
+61882226000
Fax 7610 0
Email 7610 0
drvasanthrao@yahoo.com

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.