In this research we try to use a RCT to compare analgesia of spinal versus epidural analgesia to decrease delivery pain in pregnant women.The goal of this research is to compare two procedures.finally evaluate the best procedure for analgesia of delivery in all pregnant womens.Two groups of spinal and epidural patients in 100 pregnant women, for spinal procedure we use needle 25 gauge in L4 or L5 lumbar space and for epidural procedure we use needle 17 gauge with loss of Resistance technique for injection.variants in this research includes hypotension,duration of analgesia,visual analouge scale,evaluation of consciousness,itching ans etc.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042927667N1
Registration date:2016-06-16, 1395/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-16, 1395/03/27
Registrant information
Name
Abbas Ahmadi
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 918 859 6723
Email address
abbas.ahmadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Science
Expected recruitment start date
2015-01-20, 1393/10/30
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of Spinal Analgesia Versus Epidural Analgesia In Pregnant Patients
Public title
Comparative Evaluation of Spinal Analgesia Versus Epidural Analgesia In Pregnant Patients
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria:all pregnant women
exclusion criteria:1-any history of addiction
2-INR more than1/4
3.platelet count less than 100000
4-any acceptance to stay in each stage of survey
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciense
Street address
Number 2 deparment of Kermanshah University of Medical Sciense , Shahid behest Boulevard, Kermanshah
City
Kermanshah
Postal code
6718754399
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
KUMS.REC.1394.464
Health conditions studied
1
Description of health condition studied
ANESTHESIA BLOCK AND DELIVERY
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery
Primary outcomes
1
Description
DUE TO QUESTIONAIR OF VISUAL ANALOGUE SCALE
Timepoint
EVALAUATION DUE TO SERIAL MINUTES 5/15/30/45/60/90/120/150
Method of measurement
PATIENTS ATTETUDE OF PAIN RELIEFE
Secondary outcomes
1
Description
EVALUATION OF NAUSEA AND VOMITING DURING PROCEDURE
Timepoint
AT THE END OF PROCEDURE
Method of measurement
IN THE QUESTIONAIRE
Intervention groups
1
Description
in this research we try to use a RCT to compare analgesia of two types of procedures to decrease delivery pain in pregnant women.intervention group include 50 pregnant patients in spinal group.
we inject 1/5 milliliter bupivacaueine ./05 % with needle 25 gauge in L4 or L5 lumbar space .
Category
Treatment - Other
2
Description
in this research we try to use a RCT to compare analgesia of two types of procedures to decrease delivery pain in pregnant women.control group include 50 pregnant patients in epidural group.
we inject 10 milliliter bupivacaueine ./01 % with needle 17 gauge in L4 or L5 lumbar space .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
IMAM REZA HOSPITAL KERMANSHAH
Full name of responsible person
Abbas Ahmadi
Street address
Education unit,Imam Reza Hospital,Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kermanshah University of Medical Science
Full name of responsible person
Farid Najafi
Street address
The Central Building of Kermanshah University of Medical Science,Beheshti Bolv,Kermanshah6715847141
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kermanshah University of Medical Science
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
Kermanshah University of Medical Science
Full name of responsible person
Abbas Ahmadi
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
The Central Building of Kermanshah University of Medical Science,Beheshti Bolv,Kermanshah6715847141
City
Kermanshah
Postal code
6718754399
Phone
+98 84 4727 8161
Fax
Email
abbas.ahmadi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Javad Aminisaman
Position
Assistant Professor
Other areas of specialty/work
Street address
The Central Building of Kermanshah University of Medical Science,Beheshti Bolv,Kermanshah6715847141
City
Kermanshah
Postal code
6718754399
Phone
+98 83 3727 8161
Fax
+98 83 3427 6343
Email
javad.aminisaman@kums.ac.ir
Web page address
http;//www.kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Abbas Ahmadi
Position
Resident ao Anesthesia
Other areas of specialty/work
Street address
The Central Building of Kermanshah University of Medical Science,Beheshti Bolv,Kermanshah6715847141
City
Kermanshah
Postal code
6718754399
Phone
+98 83 3727 8161
Fax
+98 83 3727 8161
Email
abbas.ahmadi@kums.ac.ir
Web page address
http/;www.kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)