Comparison of efficacy of combination diclofenac suppository and tranxamic acid with diclofenac suppository and tranxamic acid alone on pain and bleeding in patients undergoing spinal anesthesia for cesarean
tostoperative bleeding in patients undergoing spinal anesthesia for cesarean
Objective of study: Comparison of efficacy of combination diclofenac suppository and tranxamic acid with diclofenac suppository and tranxamic acid on pain and
tostoperative bleeding in patients undergoing spinal anesthesia for cesarean
Inclusion criteria: pregnant women aged 18 to 40 years with spinal anesthesia for elective Caesarean section and don't have underlying disease and have satisfied for spinal anesthesia. And prohibitions for spinal anesthesia and don't have any allergy to anesthetics and other drugs. hypnotics and anti-anxiety drugs. Don't use
Exclusion criteria: presence of underlying disease ban for spinal anesthesia and allergy to anesthetics and the other drugs, using hypnotics and anti-anxiety drugs in patients with hemoglobin less than 10. And patients with placenta previa and placental detachment and , placenta Acreta, placenta previa, multiple, history of thromboembolic disease and any coagulopathy patients with a BMI over 35 and kidney trouble,also people who have the problem polyhydroamnious and oligo polyhydroamnious is not in this study Population under Studying: Women 18 to 40 years old undergoing cesarean section with spinal anesthesia.
Sample Size: 210 cases (three groups of 70 people)
Intervention study and it's time: diclofenac suppository and tranxamic acid intravenously 5-10 min before spinal anesthesia.
Primary outcomes: the amount of bleeding during cesarean
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100914961N1
Registration date:2013-11-21, 1392/08/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-21, 1392/08/30
Registrant information
Name
fatemeh farajisoleymani
Name of organization / entity
medical university of qazvin
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 5741
Email address
fnarjisoleymani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2011-04-20, 1390/01/31
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of combination diclofenac suppository and tranxamic acid with diclofenac suppository and tranxamic acid alone on pain and bleeding in patients undergoing spinal anesthesia for cesarean
tostoperative bleeding in patients undergoing spinal anesthesia for cesarean
Public title
The effect of tranxamic acid and diclofenac suppository on reducing postoperative pain and bleeding in patients undergoing spinal anesthesia for cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women aged 18 to 40 years ; selection for cesarean section; full satisfaction of the spinal anesthesia;have no underlying disease; don’t have any prohibition for spinal anesthesia and allergy to anesthetics and the other drugs;not using Hypnotics and anti-anxiety drugs Exclusion criteria: presence of underlying disease;prohibition to spinal anesthesia and allergy to anesthetics and the other drugs; using hypnotics and anti-anxiety drugs; patients with hemoglobin less than 10;patients with detached placenta, placenta Acreta, placenta previa;multiple;history of thromboembolic disease ;any coagulopathy; patients with a BMI over 35 ; kidney trouble;polyhydroamnious and oligo hydroamnious
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The school of Medicineof Qazvin
Street address
The school of Medicineof Qazvin, Navab street, Qazvin
City
Qazvin
Postal code
3413996134
Approval date
2013-09-04, 1392/06/13
Ethics committee reference number
28/20/7899
Health conditions studied
1
Description of health condition studied
spinal anesthesia
ICD-10 code
O74
ICD-10 code description
Complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
the amount of bleeding during sesarian
Timepoint
during laber and 24 hours after laber
Method of measurement
according check list (calculating gas and longas during sesarian and HB 24 hours after sesarian)
2
Description
the amount of pain after cesarian
Timepoint
during laber and 24 hours after laber
Method of measurement
according to the visual pain scale
Secondary outcomes
1
Description
the level of the pain after surgery
Timepoint
24 hours afte surgery
Method of measurement
according of VPS
Intervention groups
1
Description
The first group tranxamic acid 10 cc per kilogram of body weight intravenously for 5 to 10 minutes before the start of the section,
Category
Treatment - Drugs
2
Description
The second group of diclofenac suppositories 100 mg, 5 to 10 minutes before the start of the section
Category
Treatment - Drugs
3
Description
The third group combination of tranxamic acid 10 cc per kilogram of body weight intravenously and diclofenac suppositories 100 mg for 5 to 10 minutes before the start of section
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Kosar Hospital
Full name of responsible person
Dr Fatemeh Farajisoleymani
Street address
Qazvin Rajayi Hospital
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The school of Medicine of Qazvin
Full name of responsible person
Dr Saeed Asefzadeh
Street address
Qazvin Rajayi Hospital
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The school of Medicine of Qazvin
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
The school of Medicine of Qazvin
Full name of responsible person
Dr Fatemeh Farajisoleymani
Position
The Assistent of Anesthesiology
Other areas of specialty/work
Street address
Qazvin Rajayi Hospital
City
Qazvin
Postal code
3413996134
Phone
+98 28 1333 5800
Fax
Email
fnarjisoleymani@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Babaei Medical University of Qazvin
Full name of responsible person
Dr Fatemeh Farajisoleymani
Position
The Assistent of Anesthesiology
Other areas of specialty/work
Street address
Qazvin Rajayi Hospital
City
Qazvin
Postal code
3413996134
Phone
+98 28 1333 5800
Fax
Email
fnarjisoleymani@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The school of Medicineof Qazvin
Full name of responsible person
Dr Fatemeh Farajisoleymani
Position
The Assistent of Anesthesiology
Other areas of specialty/work
Street address
Qazvin Rajayi Hospital
City
Qazvin
Postal code
3413996134
Phone
+98 28 1333 5800
Fax
Email
fnarjisoleymani@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)