Comparison of severity of pain and morphine intrathecal complications and morphine with naloxone in patients undergoing cesarean section
Design
Double-blind clinical trial with block randomized allocation and parallel group design
Settings and conduct
The patients were randomly assigned to the groups, after randomization. The collaborator who is informed to random numbers and patient grouping is responsible for registering patients' names and preparing the medication.
Subsequently, Injection of the drug is done by a collaborator unaware of the type of medication And the post-operative information is collected by unbiased collaborations of the uninformed patient.
After collecting enough samples, the patient's total information is shared with the first partner so that patients are embedded in both groups and statistical analysis can be done
Patients will receive 10 mg of 0.5 % bupivacaine plus 100 μg of morphine intrathecaly. in addition In the case group patients will receive 20 ng naloxone of Tolid daru companies
Participants/Inclusion and exclusion criteria
patents admit in Emam hospital For cesarian ,ASA classification 1or 2 and 60 -80 Kg weight and first or second pregnancy will submit to the study and Patients who used opiate drugs before cesarean section or have consumption of any medicine to reduce itching and if spinal anesthesia was unsuccessful
or if surgery prolong more than normal ; will dismissed from study
Intervention groups
Patients in both case and control group will receive 10 mg of 0.5 % bupivacaine plus 100 μg of morphine intrathecaly. in addition In the case group patients will receive 20 ng naloxone of Tolid daru companies
Main outcome variables
Patients' pain score will be evaluated based on the VAS questionnaire at 2, 4 and 6 hours after surgery and after 24 hours.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140524017811N8
Registration date:2018-12-10, 1397/09/19
Registration timing:registered_while_recruiting
Last update:2018-12-10, 1397/09/19
Update count:0
Registration date
2018-12-10, 1397/09/19
Registrant information
Name
Shayan Amjadi
Name of organization / entity
Students Research Committee,Arak Universiry of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.amjadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain severity and side effects of intrathecal injection of morphine and morphine plus Naloxone in cesarian patients
Public title
morphine plus Naloxone in cesarian
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patents admit in Emam hospital For cesarian
ASA classification 1or 2
60 -80 Kg weight
first or second pregnancy
Exclusion criteria:
Patients who used opiate drugs before cesarean section
consumption of any medicine to reduce itching
unsuccessful spinal anesthesia
prolong surgery
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization which the patient was the randomization unit.
Assignment of patients to the intervention and control group is carried out by a statistical expert by using blocks of 4 with with the help of statistical software minitab and using random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will randomly enter a group in block randomization
Medications for each group are prepared by a collaborator and available to the uninformed therapist
Also, the patients are not aware of the type of medication received
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Sari, Imam Sq, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱۴۸۱۵۷
Approval date
2018-10-09, 1397/07/17
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.13997.044
Health conditions studied
1
Description of health condition studied
cesarean
ICD-10 code
O82
ICD-10 code description
Encounter for cesarean delivery without indication
Primary outcomes
1
Description
pain
Timepoint
The pain level will be evaluated at 2, 4, 6 and after 24 hours after surgery
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
1
Description
nausia
Timepoint
it will be evaluated at 2, 4, 6 and 24 hours after surgery
Method of measurement
asking the patient
2
Description
itching
Timepoint
will be evaluated at 2, 4, 6 hours after surgery
Method of measurement
asking the patient
Intervention groups
1
Description
Intervention group: Patients in both case and control group will receive 10 mg of 0.5 % bupivacaine plus 100 μg of morphine and 20 ng naloxone of Tolid daru companies intrathecaly.
Category
Treatment - Drugs
2
Description
Control group: will receive 10 mg of 0.5 % bupivacaine plus 100 μg of morphine intrathecaly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Foad Fouladi
Street address
Imam Khomeini hospital , Amir mazandarani St, Imam Sq, Sari
City
sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3304 4000
Fax
+98 11 3336 2569
Email
mhabibi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saiedi
Street address
Mazandaran University of Medical Sciences valiye asr highway,Joybar 3way,Imam Sq,Sari
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱۴۸۱۵۷
Phone
+98 11 3304 4001
Email
mhabibi@mazmus.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Reza Habibi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini hospital , Amir mazandarani St, Imam Sq, Sari
City
sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3304 4000
Fax
+98 11 3304 4000
Email
mhabibi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Reza Habibi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini hospital , Amir mazandarani St, Imam Sq, Sariساری ،میدان امام، خیابان امیر مازندرانی ، بیمارستان امام خمینی شهر sari
City
sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3304 4000
Email
mhabibi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Reza Habibi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
ساری ،میدان امام، خیابان امیر مازندرانی ، بیمارستان امام خمینی
City
sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3304 4000
Email
mhabibi@mazums.ac.ir
Web page address
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All statistical data is available after being unidentifiable
When the data will become available and for how long
The access period is up to one year after the publication of the results
To whom data/document is available
Data is available to academic researchers
Under which criteria data/document could be used
Use of information for academic research projects is allowed
From where data/document is obtainable
corresponding author
Mohammad Reza Habibi
Imam Khomeini hospital , Amir mazandarani St, Imam Sq, Sari
+98 936 732 9790
mhabibi@mazums.ac.ir
What processes are involved for a request to access data/document
Requests for specific information should be sent by an email to the responsible author along with an explanation of why the data is needed