Arteriovenous patency rate comparison between local anesthesia and axillary The comparison between Arteriovenous fistula patency rate in local anesthesia and axillary block anesthesia at first day and 30th day post fistula creation.
Sixty patient will be randomly divided into two groups. In the first group, local anesthesia and in the second group axillary block will be performed before the operation.
Patency rate will be compared at the first and 30th day.
The patency rate is defined as appropriate blood flow(250-300 cc) within fistula which is required for effective hemodialysis.
lidocaine 1% will be used for local anesthesia in antecubital area;
and in axillary bolck lidocaine 1% is injected in the line of upper extremity in axillary area.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080329181N1
Registration date:2016-10-09, 1395/07/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-09, 1395/07/18
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research in Shahid Modaress Hospita,Shaid Behesht University of Medical Sciencesl
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Arteriovenous patency rate comparison between local anesthesia and axillary block at first day and 30th day after surgery
Public title
Arteriovenous patency rate comparison between local anesthesia and axillary block at first day and 30th day after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with end stage Failure who are candidate for arteriovenous fistula;Patients with end stage Failure who require haemodialysis ;Non diabetic patients with End Stage Renal Failure.
Exclusion Criteria:Non desirable artery or vessel to maintain fistula; insufficient anesthesia after axillary block; Allergic reaction to local anesthetic; Past surgical history in selected organ.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Arabi Avenue, Velenjak,Shahid Beheshti University of medical Science
City
Tehran
Postal code
Approval date
2016-07-22, 1395/05/01
Ethics committee reference number
IT.SBMU.RETECH.REC.1395.277
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Patency Rate
Timepoint
First and thirty
Method of measurement
Physical Examination and doppler sonography
Secondary outcomes
1
Description
Blood Flow in fistula at first day
Timepoint
First day
Method of measurement
Doppler sonograghy
Intervention groups
1
Description
Control: Local Anesthesia
Category
Treatment - Drugs
2
Description
Intervention: Axillary Block
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid University of Medical Science,Shahid Modaress Hospital
Full name of responsible person
Naser Malekpor
Street address
Shahid Modares Hospital,Fraz Street, Saadat Abad.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid University of Medical Sciences.
Full name of responsible person
Nilofar Massoudi
Street address
Shahid University of Medical Sciences, Aarabi Street,Velenjak.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid University of Medical Sciences.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Behesht University of Medical Science
Full name of responsible person
Nasser Malekpor
Position
Vascular surgeon Fellowship
Other areas of specialty/work
Street address
Shaid Behesht University of Medical Sciences,Arabi street,Velenjak.
City
Tehran
Postal code
Phone
+98 21 2207 4088
Fax
Email
Nassermalekpour@sbmu.ac.ir, massodi@sbmu.ac.ir.
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Nasser Malekpour
Position
Vascular surgeon Fellowship
Other areas of specialty/work
Street address
Shaid Behesht University of Medical Sciences,Arabi street,Velenjak.
City
Tehran
Postal code
Phone
+98 21 2207 4088
Fax
Email
Nassermalekpour@sbmu.ac.ir, massodi@sbmu.ac.ir.
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Nasser Malekpour
Position
Vascular surgeon Fellowship
Other areas of specialty/work
Street address
Shaid Behesht University of Medical Sciences,Arabi street,Velenjak.
City
Tehran
Postal code
Phone
+98 21 2207 4088
Fax
Email
Nassermalekpour@sbmu.ac.ir, massodi@sbmu.ac.ir.
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)