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Comparison of efficacy of two methods of Intera venous regional anesthesia: Use of one tourniquet versus traditional method in upper limb surgery

Protocol summary

Summary
The aim of the study: Comparison of efficacy of two methods of Intera venous regional anesthesia with use of one tourniquet versus traditional method in distal upper limb orthopedics surgery Study population: Inclusion criteria: Patients' age limit from 50 to 20 years, ASA class I, orthopedic surgery with orthopedic interest has been detected in less than 60 minutes. Exclusion criteria: Obesity, peripheral vascular disease, Raynaud's phenomenon, scleroderma, Epilepsy, sickle cell anemia, Methemoglobin, patients with any history of drug allergies and diseases such as heart disease - smoking, high blood pressure, coagulation disorders, excessive bleeding, Hb less than 10, use Calcium Canal Blockeror Beta blocker, renal failure, drug abuse and patient who did not have necessary cooperation and skin infection in axillary region Sample: 80 Patients Intervention: 5 minutes after lidocaine injection to complete sensory block occurs Vital signs and tourniquet pain patients (based on criteria VAS) at 0, 15, 30, 60 are recorded. In Group D (double tourniquet) each time the patient had complained tourniquet pain distal tourniquet was placed on the numb, inflate and the proximal tourniquet is empty and if the patient still had residual pain, narcotic (fentanyl) is injected. But in Group S (single tourniquet) just from a wider deflation (cm 12) against double tourniquet (a tourniquet cm 6) are used, as soon as the patient's pain narcotic (fentanyl) is injected and every time the patient complained of tourniquet pain, narcotics are injected.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013041111898N4
Registration date: 2013-05-07, 1392/02/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-05-07, 1392/02/17
Registrant information
Name
Ahmadreza Mirbolouk
Name of organization / entity
Guilin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 2250
Email address
ah.mirbolouk@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of two methods of Intera venous regional anesthesia: Use of one tourniquet versus traditional method in upper limb surgery
Public title
Comparison of efficacy of two methods of Intera venous regional anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients' age limit from 50 to 20 years, ASA class I, orthopedic surgery with orthopedic interest has been detected in less than 60 minutes. Exclusion criteria: Obesity, peripheral vascular disease, Raynaud's phenomenon, scleroderma, Epilepsy, sickle cell anemia, Methemoglobin, patients with any history of drug allergies and diseases such as heart disease - smoking, high blood pressure, coagulation disorders, excessive bleeding, Hb less than 10, use Calcium Canal Blockeror Beta blocker, renal failure, drug abuse and patient who did not have necessary cooperation and skin infection in axillary region
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
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
Guilan University Of Medical Sciences
Street address
Central Building of Guilan University of Medical Sciences, Opposite the Azodi Stadium, Namjoo Stree
City
Rasht
Postal code
Approval date
2013-02-09, 1391/11/21
Ethics committee reference number
1910396407

Health conditions studied

1

Description of health condition studied
Fracture of upper limb
ICD-10 code
T10
ICD-10 code description
Incl.: Broken arm NOS Fracture of arm NOS. The following subdivisions are provided for optional use in a supplementary character position where it is not possible or not desired to use multiple coding to identify fracture and open wound; a fracture not in

Primary outcomes

1

Description
VAS Score
Timepoint
0, 15, 30 & 60 min after complete sensory block occurs
Method of measurement
with VAS score based on patient report

2

Description
Complications
Timepoint
0, 15, 30 & 60 min after complete sensory block occurs
Method of measurement
Based on clinical judgment, with agitation, anxiety, seizures, impaired consciousness, cardiovascular complications

Secondary outcomes

empty

Intervention groups

1

Description
Changing tourniquet and If remain pain narcotic is injected
Category
Other

2

Description
Injection narcotic
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina hospital
Full name of responsible person
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Department, Guilan University of Medical Sciences
Full name of responsible person
Rasoul Tabari (pHD)
Street address
Research and Technology Department, Guilan University of Medical Sciences, opposite of agriculture bank, Gas _ circle
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Department, Guilan 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
Medical Student
Full name of responsible person
Mohammad Sadeq Mousavi
Position
Research and Technology Department, Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
Rasht
Postal code
Phone
+98 13 1555 2241
Fax
Email
arman.mousavi1989@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ahmadreza Mirbolouk (MD)
Position
Orthopaedic surgeon
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
Rasht
Postal code
Phone
+98 13 1322 1572
Fax
Email
mirbolouk@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Orthopaedic Research Center,Guilan University of Medical Sciences
Full name of responsible person
Mohammadsadeq Mousavi
Position
Medical Student
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
Rasht
Postal code
Phone
+98 13 1322 1572
Fax
Email
arman.mousavi1989@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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