A comparison study of different doses of isobaric Ropivacaine 0.5% in spinal anesthesia in cesarean section
Design
This study is a single-blinded clinical trial. The study population includes women who hospitalized as candidates for the cesarean section in the obstetrics and gynecology ward of Motazedi hospital in 2020. A total of 108 patients were selected conveniently and randomly assigned to three intervention groups of 36 using a random number table and there is no need to matching
Settings and conduct
This study, which will be conducted in Motazedi hospital of Kermanshah, is a single-blinded one, in this way, the data analyzer is unaware of the allocation of study groups and the drug dose that they received. At the beginning of the study, 10 ccs per kilogram of body weight of the crystalloid fluid are prescribed. Systolic and diastolic blood pressure, heart rate, and blood oxygen saturation are then measured. Sensory-motor block is performed by midline or paramedian method and using Quinke spinal needle 25 in a completely sterile condition.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cesarean section candida patients with18 and 42 years old; Weight between 60 to 90 kg; Height between 155 and 175; Gestational age equal or greater than 36 weeks
Exclusion criteria: History of coagulation problems; Increased intracranial pressure and infection at the site of needle entry; Local anesthetic allergy
Intervention groups
The first intervention group will receive 20 mg of ropivacaine 0.5% isobaric from MOLTENI company by injection.
The second intervention group will receive 22.5 mg of ropivacaine 0.5% isobaric from the MOLTENI company by injection.
The third intervention group will receive 25 mg of ropivacaine 0.5% isobaric from MOLTENI company by injection.
Main outcome variables
Patient satisfaction with spinal anesthesia, Blood pressure, Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N156
Registration date:2020-12-13, 1399/09/23
Registration timing:registered_while_recruiting
Last update:2020-12-13, 1399/09/23
Update count:0
Registration date
2020-12-13, 1399/09/23
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
2020-11-10, 1399/08/20
Expected recruitment end date
2021-02-08, 1399/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison study of different doses of isobaric Ropivacaine 0.5% in spinal anesthesia in cesarean section
Public title
Comparison of 3 doses of anesthetic for spinal anesthesia in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cesarean section patients between 18 and 42 years old
Weight between 60 to 90 kg
Height between 155 and 175
Gestational age equal or greater than 36 weeks
Exclusion criteria:
History of coagulation problems
Increased intracranial pressure
Local anesthetic allergy
Infection at the site of needle entry
Age
From 18 years old to 42 years old
Gender
Female
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Using the dice roll. In a 3-group study, the numbers 1 and 2 are considered for the first group, the numbers 3 and 4 for the second group, and the numbers 5 and 6 for the third group are considered.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer is unaware of the allocation of study groups and the dose 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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-08-18, 1399/05/28
Ethics committee reference number
ir.kums.rec.1399.561
Health conditions studied
1
Description of health condition studied
Cesarean delivery
ICD-10 code
P03.4
ICD-10 code description
Newborn (suspected to be) affected by Cesarean delivery
Primary outcomes
1
Description
Patient satisfaction with spinal anesthesia
Timepoint
After surgery
Method of measurement
Question from the patient (excellent, good, average, bad)
2
Description
Blood pressure
Timepoint
Every 3 minutes from the start of the block until the recovery clearance
Method of measurement
Monitoring device
3
Description
Heart rate
Timepoint
Every 3 minutes from the start of the block until the recovery clearance
Method of measurement
Monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 20 mg of ropivacaine 0.5% isobaric from MOLTENI company by injection.
Category
Treatment - Drugs
2
Description
The second intervention group will receive 22.5 mg of ropivacaine 0.5% isobaric from the MOLTENI company by injection.
Category
Treatment - Drugs
3
Description
The third intervention group will receive 25 mg of ropivacaine 0.5% isobaric from MOLTENI company by injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazedi Hospital
Full name of responsible person
Nahid Presidend
Street address
Motazedi Hospital, Ferdowsi Square
City
Kermanshah
Province
Kermanshah
Postal code
1447 67188
Phone
+98 83 3724 6693
Email
nahidpresidend65@Gmail.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 Boulevard
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
Nahid Presidend
Position
Anesthesia Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, parastar boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
nahidpresidend65@Gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Parisa Golfam
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, parastar boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
pargolfam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nahid Presidend
Position
Anesthesia Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, parastar boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
nahidpresidend65@Gmail.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
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
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
6 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
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 45-day timeframe