Protocol summary

Summary
After the University Ethics Committeea approval in a randomized clinical trial 60 pregnant women candidate elective cesarean section with ASA class 1 or 2 included in the study and randomly in two groups of sufentanil with bupivacain and bupivacain alone. Patients with a history of coagulopathy, lack of consent to perform the spinal anesthesia, infection, history of anesthesia ,migraine headaches, seizures, severe preeclampsia, eclampsia, a history of low back pain and any mass in the CNS are excluded. Before induction of spinal anesthesia the objective of research and telecommunication follow up with patients were described as well as how to express the pain VAS by the criteria as well as to educate them. Before performing spinal anesthesia ,patiants consent were collected and in both groups 500 cc venous fluid were infused and bood pressure, pulse oximetry heart rate were monitored. In both groups, spinal anesthesia were in sitting position in L4-L5 space with spinal Quinke needle (25 G * 90mm). in one group 12.5 mg of bupivacain injected and in other group 12.5 mg of cell bupivacain with 5 µg sufentil were injected. in the check list information of patients and phone numbers for follow up added. And up to a week the phone call will performed . patients were admitted for three days and headache occurance were evaluted,and if any headache recorded the severity of the headaches in order to VAS added(VAS zero means completely without the headache and headache imaginable ten VAS is the strongest). In the case of mild and moderate headache patient support measures recommended in the event of a severe headache that disrupt the patians daily activities recomended to return to hospital and epidural blood patch were performed by the executive producer. Finally the information collected by the software Stata11 processed and the analysis of the case performed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201610162946N8
Registration date: 2016-10-23, 1395/08/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-23, 1395/08/02
Registrant information
Name
Mitra Yari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
myari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation effect of sufentanil and bupivacaine compared to bupivacaine alone in the prevention of post-spinal headaches caused by rupture of Dora layer in pregnant women undergoing caesarean section
Public title
The evaluation effect of sufentanil and bupivacaine compared to bupivacaine alone in the prevention of post-spinal headaches caused by rupture of Dora layer in pregnant women undergoing caesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
In this study, pregnant women 18 to 40 years undergoing elective cesarean section; ASA class I, II (American Society classification ofAnesthesia); BMI of 18.5 to 25 .patiants were entered to this study after giving informed consent. Patients with a history of bleeding disorder, lack of consent to perform spinal anesthesia, infection, migraine, history of seizures, severe preeclampsia, eclampsia, history of back pain and bulky mass in the CNS are excluded.
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: 60
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
ethics committee of Kermanshah University of Medical Sciences
Street address
No. 2 building of Medical University, Shahid Beheshti boulevard
City
kermanshah
Postal code
6714415333
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
KUMS.REC.1394.497

Health conditions studied

1

Description of health condition studied
headache
ICD-10 code
g44.4
ICD-10 code description
Drug-induced headache, not elsewhere classified

Primary outcomes

1

Description
headache incidence and intencity
Timepoint
0 to 7 days after spinal anesthesia
Method of measurement
by visual analogue scale

Secondary outcomes

1

Description
vital sign changes
Timepoint
every 2 minute until 10minute then every 5 minute
Method of measurement
by datascope monitor

Intervention groups

1

Description
Spinal anesthesia is performed in sitting position between L4 - L5 spaces with spinal needle Quinke (25 G * 90mm) 12.5 mgbupivacaine with 5 mcg sufentanil used.
Category
Treatment - Drugs

2

Description
Spinal anesthesia is performed in sitting position between L4 - L5 spaces with spinal needle Quinke (25 G * 90mm) 12.5 mg bupivacaine used.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mitra Yari
Street address
Parastar boulevard, Sorkhalijeh
City
kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for reasearch ,Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Imam Reza Hospital, Parastar boulevard, Sorkhalijeh
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 reasearch ,Kermanshah University of Medical Sciences
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 Sciences
Full name of responsible person
Dr. Mitra Yari
Position
assistant professor, anesthesiologist
Other areas of specialty/work
Street address
Imam Reza Hospital, Parastar boulevard, Sorkhalijeh
City
kermanshah
Postal code
67144-15333
Phone
+98 83334334157
Fax
+98 83 3433 4667
Email
myari@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitra Yari
Position
Associated professor and anesthesiologist
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
kermanshah
Postal code
6714415333
Phone
+98 83 3427 6323
Fax
+98 83 3427 6323
Email
myari@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitra Yari
Position
assistant professor, anesthesiologist
Other areas of specialty/work
Street address
Imam Reza Hospital, Parastar boulevard, Sorkhalijeh
City
kermanshah
Postal code
67144-15333
Phone
+98 83 3427 6310
Fax
+98 83 3427 6310
Email
myari@kums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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