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Recruitment centers
#1
Name of recruitment center - English: Vali Asr Hospital, Arak
Name of recruitment center - Persian: بیمارستان ولی عصر اراک
Full name of responsible person - English: Dr. siamak rakei Isfahani
Full name of responsible person - Persian: دکتر سیامک راکعی اصفهانی
Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
Street address - Persian: اراک، سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Fax:
Email: siamakrakei@yahoo.com
Web page address:
Name of recruitment center - English: Vali Asr hospital, Arak
Name of recruitment center - Persian: بیمارستان ولی عصر اراک
Full name of responsible person - English: Dr. Siamak Rakei Isfahani
Full name of responsible person - Persian: دکتر سیامک راکعی اصفهانی
Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
Street address - Persian: اراک، سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Fax:
Email: siamakrakei@yahoo.com
Web page address:
Name of recruitment center - English: Vali Asr Hospitalhospital, Arak Name of recruitment center - Persian: بیمارستان ولی عصر اراک Full name of responsible person - English: Dr. siamak rakeiSiamak Rakei Isfahani Full name of responsible person - Persian: دکتر سیامک راکعی اصفهانی Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN Street address - Persian: اراک، سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3417 3505 Fax: Email: siamakrakei@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Alireza kamali
Full name of responsible person - Persian: دکتر علیرضا کمالی
Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
Street address - Persian: اراک، سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک، معاونت پژوهشی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Fax:
Email: alikamaliir@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Alireza Kamali
Full name of responsible person - Persian: دکتر علیرضا کمالی
Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
Street address - Persian: اراک، سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک، معاونت پژوهشی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Fax:
Email: alikamaliir@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.Alireza kamaliKamali Full name of responsible person - Persian: دکتر علیرضا کمالی Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN Street address - Persian: اراک، سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک، معاونت پژوهشی اراک City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3417 3505 Fax: Email: alikamaliir@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ghasem Habibi
Full name of responsible person - Persian: قاسم حبیبی
Position - English: General Medicine
Position - Persian: پزشکی عمومی
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge
Street address - Persian: سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Mobile: +98 912 024 9261
Fax:
Email: ghasemhabibi.chem@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ghasem Habibi
Full name of responsible person - Persian: قاسم حبیبی
Position - English: Research assistant
Position - Persian: دستیار پژوهش
Latest degree: bachelor
Area of specialty/work: 58
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge
Street address - Persian: سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3819693345
Phone: +98 86 3417 3505
Mobile: +98 912 024 9261
Fax:
Email: ghasemhabibi.chem@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ghasem Habibi Full name of responsible person - Persian: قاسم حبیبی Position - English: General MedicineResearch assistant Position - Persian: پزشکی عمومیدستیار پژوهش Latest degree: med_doctorbachelor Area of specialty/work: 3058 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge Street address - Persian: سردشت، پل بسیج، پردیس دانشگاه علوم پزشکی اراک City - English: Arak City - Persian: اراک Province: Markazi Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3819693345 Phone: +98 86 3417 3505 Mobile: +98 912 024 9261 Fax: Email: ghasemhabibi.chem@gmail.com Web page address:
Protocol summary
Study aim
Pain due to multiple (3-4) rib fractures of trauma patients compared between the thoracic epidural block and intercostal block.
Design
Clinical trial without a control group, with parallel groups, double-blind, performed on 86 patients.
Settings and conduct
The study is a randomized double-blind clinical trial in which patients with 3-4 rib fractures who are referred to Valiasr hospital in Arak who do not have pneumothorax and hemothorax are randomly divided into two groups.
The thoracic epidural or intercostal block is performed by an anesthesiologist and then the intern in charge of the project, who is unaware of the grouping, will record the patients' information including pain score, hemodynamics, etc. in the questionnaire. Also, the statistician of the project consultant, who is not aware of the groups and only analyzes the two groups A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with 3-4 rib fractures, age between 15 to 50 years, no underlying heart and lung disease, no hemothorax or pneumothorax, no pulmonary contusion, no sensitivity to marcaine and lidocaine, no drug allergy
Exclusion criteria: patient's unwillingness to participate in the plan, contraindication for epidural or intercostal block, History of drug addiction
Intervention groups
Group A: patients with the thoracic epidural block.
Group B: patients with the intercostal block.
Main outcome variables
Pain by score, mean of drug use, mean heart rate,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161017030336N8
Registration date:2021-11-23, 1400/09/02
Registration timing:retrospective
Last update:2022-08-03, 1401/05/12
Update count:1
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
Ghasem Habibi
Name of organization / entity
Islamic azad university
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 3208
Email address
dr.habibi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-04, 1400/02/14
Expected recruitment end date
2021-09-05, 1400/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between thoracic epidural and intercostal block in pain management of patients with 3-4 traumatic rib fracture
Public title
comparison between thoracic epidural and intercostal block in pain management of patients with 3-4 traumatic rib fracture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 3-4 rib fractures
Age between 15 to 50 years
Lack of underlying heart and lung disease
Absence of hemothorax and pneumothorax
Absence of pulmonary contusion
Lack of sensitivity to marcaine and lidocaine
Lack of sensitivity to drugs
Exclusion criteria:
The patient's unwillingness to participate in the plan
History of drug addiction
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
86
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Thoracic trapezius or intercostal block is performed by the anesthesiologist in charge of the project and then the intern in charge of the project who is unaware of the grouping, patient information including pain score, hemodynamics, etc. will be recorded in the questionnaire. Also, the project consultant statistician who is in charge of data analysis is not aware of the groups and only analyzes the two groups A and B.
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
Basij St., Campus of Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2021-05-03, 1400/02/13
Ethics committee reference number
IR.ARAKMU.REC.1400.002
Health conditions studied
1
Description of health condition studied
Fracture of thoracic vertebra
ICD-10 code
S22.0
ICD-10 code description
Fracture of thoracic vertebra
2
Description of health condition studied
Multiple fractures of ribs
ICD-10 code
S22.4
ICD-10 code description
Multiple fractures of ribs
Primary outcomes
1
Description
Pain
Timepoint
In 15 minutes, one hour, 2 hours, 4 hours, 12 hours, 24 hours
Method of measurement
Visual Analogue Scale. In this scale, the number zero is considered painless and the number 10 is considered the maximum amount of pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients with thoracic epidural block are placed in a sitting position after taking a vein and giving 3 cc per kg of normal saline, and after washing the area using an epidural needle 20 in the thoracic space, depending on the fracture of the ribs, we will block the patient.The desired dose for the patient using marcaine is 0.25 to 0.3 cc per kg.
Category
Treatment - Other
2
Description
Intervention group 2: Patients in the intercostal block group, after taking a vein and giving 3 cc / kg of normal saline while sitting or lying on their side, then the target area is washed and the intercostal block is prepared. Using a G22 needle and according to the fracture site, nerve block is performed through the intercostal space in the posterior region. The desired dose for inter-gear block is 0.2 cc / kg of marcaine 0.25.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr hospital, Arak
Full name of responsible person
Dr. Siamak Rakei Isfahani
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
siamakrakei@yahoo.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
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak, IR. IRAN
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
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
Ali Karbasfroshan
Position
General Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
alikarbasi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Siamak Rakei Isfahani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arak University of Medical Sciences, Sardasht, Basidj Bidge
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
siamakrakei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ghasem Habibi
Position
Research assistant
Latest degree
Bachelor
Other areas of specialty/work
Traditional Medicine
Street address
Pardis of Arak University of Medical Sciences, Sardasht, Basidj Bidge
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
ghasemhabibi.chem@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
There are no conditions for access to information.
From where data/document is obtainable
Vice Chancellor for Research, Arak University of Medical Sciences.+98 86 3417 3505
What processes are involved for a request to access data/document
The applicant can access the documents immediately after contacting the Vice Chancellor for Research of Arak University of Medical Sciences.