Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000261314
Ethics application status
Approved
Date submitted
17/01/2017
Date registered
20/02/2017
Date last updated
19/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Blood Ropivacaine level after PECS II block in patients undergoing mastectomy.
Scientific title
A prospective study of analgesic efficacy and plasma Ropivacaine concentration after PECS II block in patients undergoing mastectomy.
Secondary ID [1] 290935 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 301657 0
regional block 301658 0
mastectomy 301659 0
Condition category
Condition code
Anaesthesiology 301366 301366 0 0
Anaesthetics
Cancer 301477 301477 0 0
Breast
Surgery 301478 301478 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Venous blood will be sampled from the blood taking canulla at 0, 10, 20, 30, 45, 60, 90, and 120 minutes after PECS II block using Ropivacaine.
Intervention code [1] 296980 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300763 0
To measure the chronological changes in venous concentration of Ropivacaine after PECS II block.
Timepoint [1] 300763 0
venous concentration of Ropivacaine at 0, 10, 20, 30, 45, 60, 90, 120 minutes after PECS II block.
Primary outcome [2] 300959 0
Calculation for the time point of maximum concentration of Ropivacaine occurred (Tmax) after injection of PECS II block,
Timepoint [2] 300959 0
within two hours after injection of PECS II block.
Primary outcome [3] 300960 0
Calculation of maximum venous plasma concentration (Cmax).
Timepoint [3] 300960 0
within two hours after injection of PECS II block.
Secondary outcome [1] 330809 0
hypodermic needle will be used to test the dermatological extent of the block 30 minutes after Ropivacaine injection.
Timepoint [1] 330809 0
dermatological extent of the block 30 minutes after Ropivacaine injection.
Secondary outcome [2] 331280 0
to assess the block duration of the analgesic effect post operation.
Timepoint [2] 331280 0
The duration of the block will be evaluated by measuring the amount of time that elapsed between completion of the block and the first administration of postoperative rescue analgesia (subcutaneous Morphine 0.1mg/kg).

Eligibility
Key inclusion criteria
adult female patients undergoing unilateral mastectomy with axillary clearance will be prospectively enrolled.
Inclusion criteria:
- ASA 1, 2 and 3 (without significant liver or renal impairment)
- Age above 18 years old
- Able to give consent
- Body weight > 50kg
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient’s refusal and inability to give consent or cooperation during procedure
- Allergy or sensitivity to local anaesthetics
- BMI>35

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
patient undergoing unilateral mastectomy and agreeable for PECS II block will be offered to participate in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
30/06/2017
Actual
8/06/2017
Date of last data collection
Anticipated
30/06/2017
Actual
8/06/2017
Sample size
Target
28
Accrual to date
Final
13
Recruitment outside Australia
Country [1] 8581 0
Malaysia
State/province [1] 8581 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 295353 0
University
Name [1] 295353 0
University Malaya Medical Center
Country [1] 295353 0
Malaysia
Primary sponsor type
University
Name
University Malaya
Address
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur
Malaysia
Country
Malaysia
Secondary sponsor category [1] 294177 0
None
Name [1] 294177 0
Address [1] 294177 0
Country [1] 294177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296685 0
UMMC Medical Research Ethics Committee (MREC)
Ethics committee address [1] 296685 0
University Malaya Medical Centre
Lembah Pantai,59100
Kuala Lumpur, Malaysia.
Ethics committee country [1] 296685 0
Malaysia
Date submitted for ethics approval [1] 296685 0
06/05/2016
Approval date [1] 296685 0
03/06/2016
Ethics approval number [1] 296685 0
20165-2443

Summary
Brief summary
To measure the chronological changes in venous concentration of Ropivacaine after PECS II block, in which the calculation for the time point of maximum concentration of Ropivacaine occurred (Tmax) and maximum venous plama concentration (Cmax) are mandatory. This would determine whether the peak plasma Ropivacaine concentration level is within the safety level allowed. The venous threshold value of systemic toxicity is 2.2 microgram/ml. The result of this study might change future recommended dosing regimen for PECS II block practice using Ropivacaine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71774 0
A/Prof Mohd Shahnaz Bin Hasan
Address 71774 0
Department of Anaethesiology
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur
Malaysia
Country 71774 0
Malaysia
Phone 71774 0
+6079492052
Fax 71774 0
Email 71774 0
[email protected]
Contact person for public queries
Name 71775 0
A/Prof Mohd Shahnaz Bin Hasan
Address 71775 0
Department of Anaethesiology
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur
Malaysia
Country 71775 0
Malaysia
Phone 71775 0
+6079492052
Fax 71775 0
Email 71775 0
[email protected]
Contact person for scientific queries
Name 71776 0
A/Prof Mohd Shahnaz Bin Hasan
Address 71776 0
Department of Anaethesiology
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur
Malaysia
Country 71776 0
Malaysia
Phone 71776 0
+6079492052
Fax 71776 0
Email 71776 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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