Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000829718
Ethics application status
Approved
Date submitted
22/07/2013
Date registered
26/07/2013
Date last updated
18/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of regional anaesthesia on the vessels of the upper limb in patients operated for vascular access
Scientific title
Effect of brachial plexus block on regional hemodynamics of the upper limb in patients operated for vascular access : Supraclavicular approach versus infraclavicular approach
Secondary ID [1] 282881 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
regional hemodynamics of the upper limb after brachial plexus block 289700 0
Condition category
Condition code
Anaesthesiology 290022 290022 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Common management for both groups will include the following:

1. No pre-medication
2. Standard monitoring: ECG, non invasive blood pressure, oxymetry.
3. Peripheral venous cannulation

Supraclavicular (SB) group:
Supraclavicular block
15 ml lidocaine 2% + 15 ml bupivacaine 0.5% in a double point injection ultrasound guided supraclavicular brachial plexus block

Infraclavicular (IB) group:
Infraclavicular block
15 ml lidocaine 2% + 15 ml bupivacaine 0.5% in a triple point injection ultrasound guided infraclavicular brachial plexus block

The duration of each procedure is approximately 15 minutes
Intervention code [1] 287583 0
Treatment: Devices
Intervention code [2] 287584 0
Treatment: Surgery
Comparator / control treatment
Infraclavicular block
Control group
Active

Outcomes
Primary outcome [1] 290072 0
brachial artery blood flow measured with ultrasound-doppler at mid arm
Timepoint [1] 290072 0
T0: before performing the block
T15: 15 minutes after the procedure is completed
T30: 30 minutes after the procedure is completed
Primary outcome [2] 290073 0
cephalic vein diameter measured with ultrasound at mid arm
Timepoint [2] 290073 0
T0: before performing the block
T15: 15 minutes after the procedure is completed
T30: 30 minutes after the procedure is completed
Primary outcome [3] 290074 0
brachial artery pulsatility and resistivity indexes measured with ultrasound-doppler at mid arm
Timepoint [3] 290074 0
T0: before performing the block
T15: 15 minutes after the procedure is completed
T30: 30 minutes after the procedure is completed
Secondary outcome [1] 303888 0
Success rate for surgical anaesthesia : seccess is defined by the absence of pain at skin incision
Timepoint [1] 303888 0
40 minutes, after the procedure is completed

Eligibility
Key inclusion criteria
Patients requiring hemodialysis and scheuled to elective confection of humeral-cephalic arteriovenous fistula under regional anaesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal
2. Allergy to local anesthetics
3. Existing neurological disorders, neuropathy of the operative extremity
4. Infection at site of needle puncture
5. Coagulation disorders

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)
Subjects for the study will be recruited from the operating list
Allocation to study groups will use sealed opaque envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
15/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5239 0
Tunisia
State/province [1] 5239 0

Funding & Sponsors
Funding source category [1] 287669 0
Hospital
Name [1] 287669 0
Military Hospital of Tunis
Country [1] 287669 0
Tunisia
Primary sponsor type
Hospital
Name
Military Hospital of Tunis
Address
Montfleury 1089 Tunis
Country
Tunisia
Secondary sponsor category [1] 286405 0
None
Name [1] 286405 0
Address [1] 286405 0
Country [1] 286405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289633 0
Military Hospital of Tunis Local Ethics Committee
Ethics committee address [1] 289633 0
Military Hospital of Tunis
Monfleury
1089
Tunis
Ethics committee country [1] 289633 0
Tunisia
Date submitted for ethics approval [1] 289633 0
Approval date [1] 289633 0
04/06/2013
Ethics approval number [1] 289633 0
063/013

Summary
Brief summary
To determine whether ultrasound guided supraclavicular block provides more important increase in brachial artery blood flow and more important vasodilation of the cephalic vein than infraclavicular block.
If the primary hypothesis is confirmed, this study will provide evidence supporting the use of the supraclavicular block for the confection of humeral-cephalic arteriovenous fistula.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41646 0
Dr Radhouane Bousselmi
Address 41646 0
Military Hospital of Tunis
15 Avenue de la Republique
2000
Bardo
Country 41646 0
Tunisia
Phone 41646 0
+216 22 622 495
Fax 41646 0
Email 41646 0
[email protected]
Contact person for public queries
Name 41647 0
Dr Radhouane Bousselmi
Address 41647 0
Military Hospital of Tunis
15 Avenue de la Republique
2000
Bardo
Country 41647 0
Tunisia
Phone 41647 0
+216 22 622 495
Fax 41647 0
Email 41647 0
[email protected]
Contact person for scientific queries
Name 41648 0
Dr Radhouane Bousselmi
Address 41648 0
Military Hospital of Tunis
15 Avenue de la Republique
2000
Bardo
Country 41648 0
Tunisia
Phone 41648 0
+216 22 622 495
Fax 41648 0
Email 41648 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
No additional documents have been identified.