The comparison effect of Dexamethasone and Morphine administration (intravenous, intrathecal and local) in pain control following lumbar spinal surgery
The comparison effect of Dexamethasone and Morphine administration (intravenous, intrathecal and local) in pain control following lumbar spinal surgery
Design
Single blinded clinical trial on 75 patients in three parallel groups
Settings and conduct
Sampling is done in Shahid Rajaee hospital to evaluate the severity of pain after lumbar spine surgery. Patients are divided in three groups of 25 cases by using colored cards.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients candidates for Discectomy, Laminectomy and fusion in more than one segment.
Exclusion criteria: Trauma patients, tumor of the lumbar region, rheumatologic and metabolic diseases, cardiovascular disease, drug allergy to Morphine
addiction history, non-completion of conservative treatment, previous lumbar spine surgery, BMI index at least 35, surgical complications such as surgical site infection, hematoma, and drug side effects such as apnea
Intervention groups
Group A: Put a surgery cell on dura site which impregnated with 2 mg of Morphine and 0.1 mg/kg of Dexamethasone
Group B: Injection of 0.02 mg/kg Morphine and 0.1 mg/kg Dexamethasone using the interatecal method
Group C: Injection of 0.1 to 0.2 mg/kg Morphine and 0.1 mg/kg Dexamethasone intravenously before closure of the surgical site
Main outcome variables
Pain after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023270N2
Registration date:2018-07-12, 1397/04/21
Registration timing:registered_while_recruiting
Last update:2018-07-12, 1397/04/21
Update count:0
Registration date
2018-07-12, 1397/04/21
Registrant information
Name
Mohsen Hasani barzi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6005
Email address
smbarzi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of Dexamethasone and Morphine administration (intravenous, intrathecal and local) in pain control following lumbar spinal surgery
Public title
The effect of Dexamethasone and Morphine administration by three methods on pain control after lumbar spinal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidates for discectomy, laminectomy and fusion in more than one segment.
Exclusion criteria:
Trauma patients, tumor of the lumbar region, rheumatologic and metabolic diseases, cardiovascular disease
Drug sensitivity to Morphine
Addiction history
Non-completion of conservative treatment
Previous lumbar spine surgery
BMI index at least 35
Surgical complications such as surgical site infection
Hematoma, and drug side effects such as apnea
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are divided in three groups (25 cases) by using colorful cards.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.QUMS.REC.1395.213
Health conditions studied
1
Description of health condition studied
Lumbar spinal disease
ICD-10 code
S34.10
ICD-10 code description
Unspecified injury to lumbar spinal cord
Primary outcomes
1
Description
Pain
Timepoint
At 6، 12، 24، and 48 hours after surgery
Method of measurement
Visual analogues scale
Secondary outcomes
1
Description
Vomiting and nausea
Timepoint
At 6، 12، 24 and 48 hours after surgery
Method of measurement
Observation
2
Description
Total amount of Morphine requirement
Timepoint
At 6، 12، 24 and 48 hours after surgery
Method of measurement
Interview with patient
Intervention groups
1
Description
Intervention group: Group A: Putting a surgi-cell in dura site which impregnated with 2 mg of Morphine and 0.1 mg/kg of Dexamethasone
Category
Treatment - Drugs
2
Description
Intervention group: Group B: Injection of 0.02 mg/kg Morphine and 0.1 mg/kg Dexamethasone using the interatecal method
Category
Treatment - Other
3
Description
Intervention group: Group C: Injection of 0.1 to 0.2 mg/kg Morphine and 0.1 mg/kg Dexamethasone intravenously before closure of the surgical site
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee hospital
Full name of responsible person
Bahareh Behnam Ghader
Street address
Padegan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
b.behnamghader6@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Bahareh Behnam Ghader
Street address
Shahid Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
b.behnamghader6@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Bahareh Behnam Ghader
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Padegan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
b.behnamghader6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Seyed Mohsen Hasani Barzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Padegan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
smbarzi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Bahareh Behnam Ghader
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Padegan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
b.behnamghader6@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document