Protocol summary

Study aim
Comparison of onset, duration and quality of supraclavicular block using 0.5% bupivacaine with magnesium sulphate , ketamine and neostigmine in forearm orthopedic surgery
Design
The study will be double blind and clinical trial. 90 patients will be randomly divided into 3 groups. The groups will be parallel. The trial phase will be 3.
Settings and conduct
Candidates forearm orthopedic surgery in Valiasr Hospital in Arak are divided into 3 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:20 -70 years ,candidate for upper limb orthopedic surgery ,no more than one fracture in the body or surgery ,no blood coagulation diseases and disorders in PTT, PT and INR ,body mass index less than 35 ,lack of psychological problems ,no pregnant ,absence of neurological disorders in the hand ,no allergies to drugs used ,absence of chronic pain syndrome Exclusion criteria:Lack of patient cooperation to perform the block ,block failure ,surgery time less than 50 and more than 150 minutes ,need for more sedation than stated in the plan
Intervention groups
Intervention group 1: 25 milliliter of 0.5% bupivacaine with 100 milligram of magnesium sulfate (1 millilite of 10% solution) is prescribed. (Bupivacaine by Strazenka UK-Magnesium Sulfate by Shahid Ghazi Co in Tabriz) Intervention group: 25millilite of bupivacaine 0.5% with 2 milligram in kilogram of ketamine is prescribed. (Ketamine made by Rotex Medica - Germany) Intervention group 3:25 millilite of 0.5% bupivacaine with 500 micrograms of neostigmine is prescribed. (Neostigmine ampoule made by Caspian Tamin Co - Rasht)
Main outcome variables
Pain, narcotics consumption, sensory block, motor block

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N158
Registration date: 2021-05-11, 1400/02/21
Registration timing: prospective

Last update: 2021-05-11, 1400/02/21
Update count: 0
Registration date
2021-05-11, 1400/02/21
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
2021-05-22, 1400/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of onset, duration and quality of supraclavicular block using 0.5% bupivacaine with magnesium sulphate , ketamine and neostigmine in forearm orthopedic surgery
Public title
Comparison of onset, duration and quality of supraclavicular block using 0.5% bupivacaine with magnesium sulphate , ketamine and neostigmine in forearm orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 -70 years Candidate for upper limb orthopedic surgery No more than one fracture in the body or surgery No blood coagulation diseases and disorders in PTT, PT and INR Body mass index less than 35 Lack of psychological problems No pregnant Absence of neurological disorders in the hand No allergies to drugs used Absence of chronic pain syndrome
Exclusion criteria:
Lack of patient cooperation to perform the block Block failure Surgery time less than 50 and more than 150 minutes Need for more sedation than stated in the plan
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: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 3 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
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.ARAKMU.REC.1400.001

Health conditions studied

1

Description of health condition studied
Forearm orthopedic surgery
ICD-10 code
S52.9
ICD-10 code description
Unspecified fracture of forearm

Primary outcomes

1

Description
Pain
Timepoint
In recovery and 2 ,4, 8, 12 and 24 hours after surgery
Method of measurement
Visual analog scale of pain

2

Description
Narcotics consumption
Timepoint
24 hours after surgery
Method of measurement
Observation

3

Description
Sensory block
Timepoint
Every 1 minute
Method of measurement
chronometer

4

Description
Motor block
Timepoint
Every 5 minute
Method of measurement
chronometer

Secondary outcomes

empty

Intervention groups

1

Description
ntervention group 1: 25 milliliter of 0.5% bupivacaine with 100 milligram of magnesium sulfate (1 millilite of 10% solution) is prescribed. (Bupivacaine by Strazenka UK-Magnesium Sulfate by Shahid Ghazi Co in Tabriz)
Category
Treatment - Drugs

2

Description
Intervention group 2: 25millilite of bupivacaine 0.5% with 2 milligram in kilogram of ketamine is prescribed. (Ketamine made by Rotex Medica - Germany)
Category
Treatment - Drugs

3

Description
Intervention group 3:25 millilite of 0.5% bupivacaine with 500 micrograms of neostigmine is prescribed. (Neostigmine ampoule made by Caspian Tamin Co - Rasht)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Esmaeel Moshiri
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
moshiri@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 Bijan Yazdi
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
Fax
+98 86 3222 2003
Email
yazdi@arakmu.ac.ir

Person responsible for scientific 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 updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Habib Nadimi Bojnedi
Position
medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
habibnadimi.kobib@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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