Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000872730
Ethics application status
Approved
Date submitted
4/08/2013
Date registered
6/08/2013
Date last updated
18/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of regional anaesthesia with infraclavicular brachial plexus block on the vessels of the upper arm operated for vascular access
Scientific title
Variations of the regional hemodynamics of the upper arm after infraclavicular brachial plexus block in adults operated for vascular access
Secondary ID [1] 282956 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 infraclavicular brachial plexus block 289782 0
Condition category
Condition code
Anaesthesiology 290133 290133 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. No pre-medication

2. Standard monitoring: ECG, non invasive blood pressure, oxymetry.

3. Peripheral venous cannulation

4. Ultrasound guided infraclavicular block using 15 ml lidocaine 2% + 15 ml bupivacaine 0.5% with a triple point injection

The duration of each procedure is approximately 15 minutes
Intervention code [1] 287666 0
Treatment: Devices
Intervention code [2] 287667 0
Treatment: Surgery
Intervention code [3] 287681 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290160 0
brachial artery blood flow measured with ultrasound-doppler at mid arm
Timepoint [1] 290160 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] 290161 0
cephalic vein diameter measured with ultrasound at mid arm
Timepoint [2] 290161 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] 290162 0
brachial artery pulsatility and resistivity indexes measured with ultrasound-doppler at mid arm
Timepoint [3] 290162 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] 304035 0
Success rate for surgical anaesthesia : seccess is defined by the absence of pain at skin incision
Timepoint [1] 304035 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects for the study will be recruited from the operating list
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
2/07/2013
Date of last participant enrolment
Anticipated
Actual
12/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 5261 0
Tunisia
State/province [1] 5261 0

Funding & Sponsors
Funding source category [1] 287733 0
Hospital
Name [1] 287733 0
Military Hospital of Tunis
Country [1] 287733 0
Tunisia
Primary sponsor type
Hospital
Name
Military Hospital of Tunis
Address
Montfleury 1089 Tunis
Country
Tunisia
Secondary sponsor category [1] 286460 0
None
Name [1] 286460 0
Address [1] 286460 0
Country [1] 286460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289688 0
Military Hospital of Tunis Local Ethics Committee
Ethics committee address [1] 289688 0
Ethics committee country [1] 289688 0
Tunisia
Date submitted for ethics approval [1] 289688 0
Approval date [1] 289688 0
04/06/2013
Ethics approval number [1] 289688 0
062/013

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

Contacts
Principal investigator
Name 41962 0
Dr Radhouane Bousselmi
Address 41962 0
Military Hospital of Tunis 15 Avenue de la Republique 2000 Bardo
Country 41962 0
Tunisia
Phone 41962 0
+216 22 622 495
Fax 41962 0
Email 41962 0
[email protected]
Contact person for public queries
Name 41963 0
Radhouane Bousselmi
Address 41963 0
Military Hospital of Tunis 15 Avenue de la Republique 2000 Bardo
Country 41963 0
Tunisia
Phone 41963 0
+216 22 622 495
Fax 41963 0
Email 41963 0
[email protected]
Contact person for scientific queries
Name 41964 0
Radhouane Bousselmi
Address 41964 0
Military Hospital of Tunis 15 Avenue de la Republique 2000 Bardo
Country 41964 0
Tunisia
Phone 41964 0
+216 22 622 495
Fax 41964 0
Email 41964 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.