A comparative study of the effect of gabapentin with and without high doses of vitamin C on the reduction of morphine consumption after lumbar disc surgery
A comparative study of the effect of gabapentin with and without high doses of vitamin C on the reduction of morphine consumption after lumbar disc surgery
Design
This study is one-blinded clinical trial.The study population will included all patients with spinal surgery who referred to Imam Reza hospital of Kermanshah city.100 eligible patients will be selected conveniently and randomly will be assigned to two intervention groups.
Settings and conduct
This study that will be conducted in Imam Reza hospital of Kermanshah city is one-blinded one in this way that Clinical caregiver will be unaware of participants coding and the dose of the drug that groups will receive.To measure the severity of the pain, a ruler is marked that 0 is the sign of lack of pain and 10 is the sign of severe pain that is experienced by the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients undergoing spinal surgery
Exclusion criteria:Patients with narcotic allergies; History of alcohol and drug abuse; History of seizure;Psychopathy
Intervention groups
The first intervention group will received two grams of vitamin C before injection. The second intervention group will received 400 mg of gabatanin intravenously
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N119
Registration date:2019-04-22, 1398/02/02
Registration timing:prospective
Last update:2019-04-22, 1398/02/02
Update count:0
Registration date
2019-04-22, 1398/02/02
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-10, 1398/02/20
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of gabapentin with and without high doses of vitamin C on the reduction of morphine consumption after lumbar disc surgery
Public title
Comparison of the effect of gabapentin with and without high doses of vitamin C on the reduction of morphine consumption after lumbar disc surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing spinal surgery
Exclusion criteria:
Patients with narcotic allergies
History of alcohol and drug abuse
History of gabapentin allergy
Use of analgesics 48 hours before surgery
History of seizure
Psychopathy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, Clinical caregiver will be kept blind to study groups, the dosage of the drug and manufacturer of the drug. In this way,the clinicians are unaware of participants coding and the dose of the drug that groups will receive
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
ir.kums.rec.1398.040
Health conditions studied
1
Description of health condition studied
Lumbar Disk Herniation
ICD-10 code
G55.1*
ICD-10 code description
Nerve root and plexus compressions in intervertebral disc disorders
Primary outcomes
1
Description
Pain
Timepoint
Immediately after surgery, 48, 36, 24, 12, 6, 2, and 1 hour after surgery
Method of measurement
Using the ruler degree
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will received two grams of vitamin C before injection.
Category
Treatment - Drugs
2
Description
The second intervention group will received 400 mg of gabatanin intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital, Parastar Boulevard
Full name of responsible person
Peyman Heyrati
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Pheyrati@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Peyman Heyrati
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Pheyrati@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hassanali Karimpour
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
ha_karimpour@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Peyman Heyrati
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Pheyrati@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 35-day period, the documents will be sent e-mail