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The comparison of the effect of intravenous regional anesthesia (IVRA) with single-cuff forearm and upper arm tourniquets on the pain of patients undergoing elective hand surgery

Protocol summary

Study aim
The comparison of the effect of intravenous regional anesthesia (IVRA) with single-cuff forearm and upper arm tourniquets on the pain of patients undergoing elective hand surgery
Design
A randomized clinical trial with parallel groups. 60 patients have randomly divided into intervention groups A and B with a table of random numbers and Randomizer software.
Settings and conduct
The population of this study was aged 20-60 years old who referred to Ayatollah Rouhani Hospital in Babol. Patients are randomly divided into two Intervention groups with a Table of random numbers by computer. Intervention group A: use of a single tourniquet in the forearm (distal) + lidocaine intravenous injection of 100 mg Intervention group B: use of a single tourniquet in the upper arm (proximal) + lidocaine intravenous injection of 200 mg.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 20--60 years old, Patients undergoing hand surgeries ASA ClassI, II Exclusion Criteria: Psychologic, patients Addiction, History of allergy to local anesthetics, Epilepsy History of peripheral vascular disease, Coagulopathy, Pregnancy, Open wound in operation
Intervention groups
Intervention group A: use of a single tourniquet in the forearm (distal) + lidocaine intravenous injection of 100 mg Intervention group B: use of a single tourniquet in the upper arm (proximal) + lidocaine intravenous injection of 200 mg.
Main outcome variables
Anesthesia quality, the onset of local anesthetic effect, change in anesthetic method, duration of analgesia, pain intensity of the area, the duration of pain in the area of operation, pain intensity of the tourniquet (arm/forearm)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101213005381N13
Registration date: 2019-01-26, 1397/11/06
Registration timing: registered_while_recruiting

Last update: 2019-01-26, 1397/11/06
Update count: 0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Nadia Banihashem
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 38296
Email address
nbanihashem@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of intravenous regional anesthesia (IVRA) with single-cuff forearm and upper arm tourniquets on the pain of patients undergoing elective hand surgery
Public title
Effect of intravenous regional anesthesia in Hand surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20--60 years old Patients undergoing hand surgeries ASA ClassI,II
Exclusion criteria:
Psychologic patients Addiction History of allergy to local anesthetics Epilepsy History of peripheral vascular disease Coagulopathy Pregnancy Open wound in operation site
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients into two intervention groups Patients are randomly divided into two groups A and B with a table of random numbers (a random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized, then samples are randomly selected by Randomizer software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2018-12-16, 1397/09/25
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.208

Health conditions studied

1

Description of health condition studied
injury of wrist, hand and fingers
ICD-10 code
S60
ICD-10 code description
Superficial injury of wrist, hand and fingers

Primary outcomes

1

Description
Analgesia
Timepoint
1, 5, 10, 20, 30 mints after tornique inflation & 1, 5, 10 mints & 2 hours after unfastening the tornique
Method of measurement
Visual Analogue Scale - Visual -questionnaire

Secondary outcomes

1

Description
Time to the beginning of tourniquet pain
Timepoint
Once when the patient complained
Method of measurement
Time elapsed from tourniquet inflation in minutes

2

Description
Time to the first request for analgesic
Timepoint
Once at the moment of first request
Method of measurement
Time elapsed from tourniquet deflation in minutes

Intervention groups

1

Description
Intervention group A: Use of a single tourniquet in the forearm (distal) + lidocaine intravenous injection of 100 mg
Category
Treatment - Other

2

Description
Intervention group B: Use of a single tourniquet in the upper arm (proximal) + lidocaine intravenous injection of 200 mg
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Nadia Banihashem
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3223 8301
Email
nbanihashem@mubabol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 9595
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nadia Banihashem
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3223 8301
Email
nbanihashem@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nadia Banihashem
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11322338301
Email
nbanihashem@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Massomeh Mousavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3223 8301
Email
Musavy_sm@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is still no plan for its puplish
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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