Comparison characteristics of Supraclavicular block with bupivacaine 0.5% plus dexmedetomidine and granisetron and Magnesium sulphate in upper extremity orthopedic surgeries
Comparison characteristics of Supraclavicular block with bupivacaine 0.5% plus dexmedetomidine and granisetron and Magnesium sulphate in upper extremity orthopedic surgeries
Design
This study is clinical trial and double blind. The sample size is 105 people. Patients will be divided in 3 groups by simple randomization.Groups are parallel.Trial phase is 3.
Settings and conduct
Patients candidate for upper limb orthopedic surgery in Valiasr hospital in Arak will enter this study. This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Both of gender, 20 to 70 years, ASA class I and II, candidate for orthopedic surgery of upper limb, body mass index lower than 35
Exclusion criteria: Existence of more than one fracture in the body or surgery, coagulation diseases and abnormalities in PTT, PT and INR, psychological problems, pregnancy, neurological disorders in hand
Intervention groups
First group(Dexmedetomidine):We will inject 25 milliliter Bupivacaine 0.5% plus 1 micro gram in kilogram Dexmedetomidine.
Second group(magnesium sulfate):We will inject 25 milliliter Bupivacaine 0.5% plus100 milligram of diluted magnesium sulfate with 2 milliliter of normal saline.
Third group(Granisetron): We will inject 25 milliliter Bupivacaine 0.5% plus 3 milligram(3milliliter)Granisetron.
Main outcome variables
Sensory block duration, motor block duration, mean drug use, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N125
Registration date:2019-12-13, 1398/09/22
Registration timing:registered_while_recruiting
Last update:2019-12-13, 1398/09/22
Update count:0
Registration date
2019-12-13, 1398/09/22
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
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison characteristics of Supraclavicular block with bupivacaine 0.5% plus dexmedetomidine and granisetron and Magnesium sulphate in upper extremity orthopedic surgeries
Public title
Comparison characteristics of Supraclavicular block with bupivacaine 0.5% plus dexmedetomidine and granisetron and Magnesium sulphate in upper extremity orthopedic surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both of gender
20 to 70 years
ASA class I and II
Candidate for orthopedic surgery of upper limb
Body mass index lower than 35
Exclusion criteria:
There is more than one body fracture or surgery
Coagulation diseases and disorders in PT,PTT, INR
Psychological problems
Pregnancy
Neurological disorders in the hand
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in three groups A and B and C.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer and participant 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 drugs in each group are prepared by the anesthesiologist. They are covered with letters A, B and C. Block is performed by a specialist assistant who is unaware of the medication and interns complete the questionnaires.Internet are also unaware of grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-09-22, 1398/06/31
Ethics committee reference number
IR.ARAKMU.REC.1398.180
Health conditions studied
1
Description of health condition studied
Upper extremity fractures
ICD-10 code
S52.9
ICD-10 code description
Unspecified fracture of forearm
Primary outcomes
1
Description
Duration of motor block
Timepoint
Every 5 minute
Method of measurement
Physical examination
2
Description
Duration of Sensory block
Timepoint
Every 1 minute
Method of measurement
Physical examination
3
Description
Pain
Timepoint
Recovery and 2 and 4 and 8 and 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: We will inject 25 milliliter Bupivacaine 0.5% plus 1 micro gram in kilogram Dexmedetomidine.
Category
Treatment - Drugs
2
Description
Intervention group 2: We will inject 25 milliliter Bupivacaine 0.5% plus 100 milligram of diluted magnesium sulfate with 2 milliliter of normal saline.
Category
Treatment - Drugs
3
Description
Intervention group 3: We will inject 25 milliliter Bupivacaine 0.5% plus 3 milligram(3 milliliter)Granisetron.
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 Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
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 Behnam Mahmodie
Position
Assistant 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
mahmodie@arakmu.ac.ir
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