Comparison of the effect of rupivacaine - Dexedodomidine and rupivacaine - fentanyl on reduction of acute pain after cesarean section by epidural
Design
After obtaining permission from the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences and approving the Imam Khomeini Hospital Pain Research Center, 80 patients (first and second abdomen) between the ages of 18 and 30 with (BMI = 20-25) candidate for surgery Elective cesarean section with ASA class II and I as input criteria is randomly divided into groups A and B.
All patients will be provided written informed consent to participate in the project.
group A, rupivacaine (120 mg / kg) - dexmedetomidine (1 microgram / kg) group B, rupivacaine (120 mg / kg) - fentanyl (20 microgram / kg) they receive.
Settings and conduct
The study is a double blind clinical trial. The study site is Imam Khomeini Hospital in Ahvaz.
Participants/Inclusion and exclusion criteria
Eighty patients (first and second abdomen) between 18-30 years who are candidates for elective cesarean section with ASA class I and II are considered as input factors.
As the output of the study, preterm labor (less than 37 weeks) asthma, cardiovascular disease, preeclampsia, history of seizures, conversion to spinal anesthesia to complete anesthesia, history of chronic pain such as low back pain and fibromyalgia, as well as opioid use and mood and psychologic disorders , were considered
Intervention groups
Group 1: Rupivacaine - Dexmedicomidine
Group 2: Rupivacaine - Fentanyl
Main outcome variables
ropivacaine
fentanyl
dexamethidine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191026045246N1
Registration date:2020-02-27, 1398/12/08
Registration timing:registered_while_recruiting
Last update:2020-02-27, 1398/12/08
Update count:0
Registration date
2020-02-27, 1398/12/08
Registrant information
Name
Anahita Kalantari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8414
Email address
kalantar-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-07, 1398/11/18
Expected recruitment end date
2020-09-17, 1399/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rupivacaine - Dexedodomidine and rupivacaine - fentanyl on reduction of acute pain after cesarean section by epidural
Public title
Comparison of the effect of rupivacaine - Dexedodomidineon reduction of acute pain after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elective Cesarean section with Class I and II ASA
Exclusion criteria:
Preterm labor (less than 37 weeks)
asthma
cardiovascular disease
preeclampsia
history of seizures,
becoming spinal anesthesia to complete anesthesia
history of chronic pain such as low back pain and fibromyalgia,
opioid use
mood and Psychological disorders
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, block
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, principal investigator, especially in trials initiated by academic researchers, health care personnel (physicians, nurses, physiotherapists, etc.) responsible for patient care, data collection officers, and those who evaluate the outcome and, to a lesser extent, data safety and monitoring committee are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee Acts of Ahvaz Jundishapur University of Medical Science
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-10-11, 1398/07/19
Ethics committee reference number
IR.AJUMS.REC.1398.517
Health conditions studied
1
Description of health condition studied
cesarean section
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
2, 4, 8, 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
The patient's first time complaining of pain
Timepoint
The first time a patient feels pain after surgery
Method of measurement
Minutes
2
Description
The amount of analgesic drug
Timepoint
The onset of pain
Method of measurement
Mg / kg
3
Description
rupivacaine
Timepoint
Before surgery
Method of measurement
Mg / kg
4
Description
Dexedodomidine
Timepoint
Before surgery
Method of measurement
Mg / kg
5
Description
fentanyl
Timepoint
Before surgery
Method of measurement
Mg / kg
Intervention groups
1
Description
Intervention group: rupivacaine - Dexedodomidine
Category
Treatment - Drugs
2
Description
Intervention group: rupivacaine - fentanyl
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Anahita Kalantari
Street address
Azadegan Street - Imam Khomeini hospital of Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
kalantar-h@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Street address
Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8414
Email
rezaakh@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8414
Email
rezaakh@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8414
Email
rezaakh@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Anahita Kalantari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8414
Email
anah_ita@yahoo.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
All potential data can be shared after unidentifiable people
When the data will become available and for how long
Start access period 6 months after publishing results "
To whom data/document is available
The data for this study will only be available to researchers working in academia
Under which criteria data/document could be used
There is no specific requirement
From where data/document is obtainable
Reza Akhondzadeh
rezaakh@hotmail.com
What processes are involved for a request to access data/document