In this randomized clinical trial, with purpose of Comparing thoracic epidural infusion of Bupivacain versus Bupivacain plus dexmedetomidine in pain control of patients with multiple ribs fractures, 64 trauma patients aged over 18 years old suffering from multiple (2 or more) unilateral rib fractures will be allocated to either pain control groups. This study will be conducted in Imam Reza medical center. Considering the inclusion and exclusion criteria, trauma patients admitted to the emergency department and suffering from multiple unilateral rib fractures will be allocated to either of the study groups. First group will receive continuous bupivacaine and dexmedetomidine through thoracic epidural catheter; whereas the second group will receive single continuous bupivacaine through thoracic epidural catheter for the first 24 hours from the admission.All patients for pain control four days measured by special table will control pain and analgesic effects of each group will collect and compare.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701299948N2
Registration date:2017-02-24, 1395/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-24, 1395/12/06
Registrant information
Name
Majid Montazer
Name of organization / entity
Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 8435
Email address
montazerma@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing thoracic epidural infusion of Bupivacain versus Bupivacain plus dexmedetomidine in pain control of patients with multiple ribs fractures.
Public title
Pain control of ribs fractures.
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria:
Traumatic patient with multiple ribs fracture greater than 2 ribs; Age after 18 y;Breathing sign due to trauma; G.C.S>=14
Exclusion criteria:
Chest wall trauma having brain or cervical vertebral trauma; Patient with hemostatsis disorder; Sensitivity to anesthetic drug; Patient without satisfaction; Systemic sepsis and local infection; Patient under mechanical ventilation; Patient with abdominal trauma; Patient without cooperation; Bilateral ribs fracture; Past history of psychological and nervous system disease and chronic analgesic users.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tabriz University of Medical Sciences
Street address
Tabriz daneshgah av.,Tabriz University of Medical Sciences. anasthesiology department
City
tabriz
Postal code
١٤٧٦٦-٥١٦٦٦
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
IR.TBZMED.REC.1395.1111
Health conditions studied
1
Description of health condition studied
Chest pain, unspecified
ICD-10 code
S22.4
ICD-10 code description
Multiple fractures of ribs
Primary outcomes
1
Description
PAIN
Timepoint
Daily for four days.
Method of measurement
by visual analoge scale
Secondary outcomes
1
Description
multiple ribs fracture, pneumothorax, arterial blood gas level
Timepoint
daily for 4 days
Method of measurement
acordding to reported statistics
2
Description
Bleeding & hematoma
Timepoint
Daily for 4 days
Method of measurement
Based on clinical symptoms and visit of peocedure site
3
Description
Pneumothorax
Timepoint
Daily for 4 days
Method of measurement
Based on clinical symptoms and C.X.Ray if suspected
Intervention groups
1
Description
blocking and catheter placement in mid portion of previously pointed ribs fracture were done .then from the same pointed site local anesthetic solution( Bupivacain 0.25%, 1.5 cc per segment per fracture site after dosage test were injected. then catheter was ind-welled and (bupivacain 0.125%, 1ml/kg/hr infusion + dexmedetomidine 1 micro gram/kg bolus) was begin. each group was test for A.B.G for 4 days and oxygenation parameters is recorded.
Category
Treatment - Drugs
2
Description
In second group of patient thoracic epidural such the other group was done. then after primary bolus dose was injected (bupivacain 0.25% , 1.5 ml per ribs fracture segments bolus then bupivacain 0.125%, 1 ml/kg/hr was infused).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Maryam Hoseini
Street address
Tabriz University of medical science
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer
Street address
Tabriz, Imam Reza Hospital,Operating Room
City
Tabriz
Grant name
صفر
Grant code / Reference number
ندارد
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
maryam hoseini
Position
anasthesia rezident
Other areas of specialty/work
Street address
tabriz , Imam Reza Hospital operating room
City
Tabriz
Postal code
5166614766
Phone
+98 41 3334 1994
Fax
Email
hoseini59maryam@gmail.com
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer Bavil Oliaii M.D
Position
General Toracic Subspeciality,Assistant Professor
Other areas of specialty/work
Street address
Thorax ward, Imam Reza Hospital, Tabriz Tabriz
City
Tabriz
Postal code
1476651666
Phone
+98 41 3334 7054
Fax
+98 41 3334 1705
Email
montazer55@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer Bavil Oliaii M.D
Position
General Toracic Subspeciality
Other areas of specialty/work
Street address
Thorax ward, Imam Reza Hospital, Tabriz Tabriz
City
Tabriz
Postal code
1476651666
Phone
+98 41 3334 7054
Fax
+98 41 3334 1705
Email
montazer55@yahoo.com
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)