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
The Queen Elizabeth Hospital
Ethics DX 465101
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
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
This is a pilot study looking into safety of giving bolus of ropivacaine followed by continous infusion for 48 hrs in Transversus Abdominis Plane Block. Safety of this regime will be established by serial blood samples to analyse toal & free ropivacaine concentration , Serail ECG 's looking into QTc interval & patient will be observed for sign & symptoms of Local anaesthetic toxicity
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
[email protected]
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
[email protected]

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
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