Protocol summary

Study aim
Comparison onset,duration and quality of axillary block with ropivacaine 0‎‏.‏‎5‎‏%‏‎ plus ‎dexmedetomidine and fentanyl‏ ‏and Verapamil in forearm surgeries ‎
Design
This study is clinical trial and double blind.105 patients candidate forearm surgery in Valiasr hospital will inter this study. We will divide patients in 3 groups by simple randomization. Groups are parallel.
Settings and conduct
This study is clinical trial and double blind.105 patients candidate forearm surgery in Valiasr hospital will inter this study. Outcome assessor and analyzer not aware from grouping. Codes of group are available to analyzer and outcome assessor.
Participants/Inclusion and exclusion criteria
Inclusion criteria:20 to 70 years, fracture of the forearm and hand, absence more than a fracture in the body or surgery, body mass index less than 35, not having blood coagulation and disorder PTT and PT and INR, lack of psychological problems, no pregnancy, absence of neurological disorders in the hand Exclusion criteria: Failure to cooperate with the patient to perform the block, allergy to drug, infection in block area, surgical time more than 150 minutes, block failure
Intervention groups
First group: We inject 40 milliliter of Ropivacaine 0.5 % plus 1 micro gram in kilogram Dexmedetomidine. Second group:We inject 40 milliliter of Ropivacaine 0.5 % plus 1 micro gram in kilogram Fentanyl. Third group:We inject 40 milliliter of Ropivacaine 0.5 % plus 2.5 milligram Verapamil in kilogram Dexmedetomidine.
Main outcome variables
blood pressure, heart rate, oxygen saturation, pain, duration motor and sensory block, drug consumption

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N111
Registration date: 2019-05-09, 1398/02/19
Registration timing: registered_while_recruiting

Last update: 2019-05-09, 1398/02/19
Update count: 0
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
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
Comparison onset,duration and quality of axillary block with ropivacaine 0‎‏.‏‎5‎‏%‏‎ plus ‎dexmedetomidine and fentanyl‏ ‏and Verapamil in forearm surgeries ‎
Public title
Comparison onset,duration and quality of axillary block with ropivacaine 0‎‏.‏‎5‎‏%‏‎ plus ‎dexmedetomidine and fentanyl‏ ‏and Verapamil in forearm surgeries ‎
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 70 years Fracture of the forearm and hand Absence more than a fracture in the body or surgery Body mass index less than 35 Not having blood coagulation and disorder  PTT and PT and INR Lack of psychological problems No pregnancy Absence of neurological disorders in the hand
Exclusion criteria:
Failure to cooperate with the patient to perform the block Allergy to drug Infection in block area Surgical time more than 150 minutes Block failure
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table in division of groups in two groups A and B and C. Randomization method: Simple randomization. Random unit: Individual. How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group. Allocation concealment:Numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B and C are available to analyzer and outcome assessor.The syringe containing the drugs are covered and labeled as A and B and C at the discretion of anesthesiology residents.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.ARAKMU.REC.1397.266

Health conditions studied

1

Description of health condition studied
Forearm surgery
ICD-10 code
S52.9
ICD-10 code description
Fracture of forearm, part unspecified

Primary outcomes

1

Description
Duration of motor block
Timepoint
Every 5 minute
Method of measurement
Minute

2

Description
Duration of Sensory block
Timepoint
Every 1minute
Method of measurement
Minute

3

Description
Pain
Timepoint
Recovery and 2, 4, 8, 12, and 24 hours after surgery
Method of measurement
Visual Analogue Scale Questionnaire

4

Description
Mean of narcotic
Timepoint
24 hour after surgery
Method of measurement
Milligram

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: We inject 40 milliliter of Ropivacaine 0.5 %(Molteni .Co.Italia) plus 1 micro gram in kilogram Dexmedetomidine( Exir.co .Iran).
Category
Treatment - Drugs

2

Description
Intervention group: We inject 40 milliliter of Ropivacaine 0.5 %(Molteni .Co.Italia) plus 1 micro gram in kilogram Fentanyl.
Category
Treatment - Drugs

3

Description
Intervention group: We inject 40 milliliter of Ropivacaine 0.5 % (Molteni .Co.Italia) plus 2.5 milligram Verapamil in kilogram Dexmedetomidine
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Esmaeel Moshiri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Shirodi street, Valiasr square, Valiasr hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
modir.he@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazanin hashemi
Position
Medicine student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Modir
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
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