Evaluation of the effect of intravenous Aminophylline on prevention of headache after spinal anesthesia in patients undergoing elective cesarean section
Effect of intravenous aminophylline on headache after spinal anesthesia in patients undergoing elective cesarean section
Design
Non randomized clinical trial with control group, parallel groups, double blind
Settings and conduct
The study will be performed at Valiasr Hospital in Birjand. All patients will be randomly divided into two groups of Bupivacaine and Aminophylline recipients and Bupivacaine and dextrose water 5% recipients. While the surgeon and the patient are unaware of the type of injection solution, the injection will be performed by the resident or anesthesia technician. Designer who is completely unaware of injectable drugs will perform all post-injection evaluations.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Pregnant women aged 15-45 years with term pregnancy;candidate for elective cesarean section.
Non inclusion criteria: Women with known allergies to amide drugs; Women who have spinal anesthesia contraindications; Women with a history of chronic headaches.
Intervention groups
The intervention group: Bupivacaine and aminophylline recipients receiving 15mg bupivacaine 0.5% and 1.5mg / kg intravenous aminophylline.
The control group: receiving bupivacaine and dextrose water 5%
Main outcome variables
Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190413043254N1
Registration date:2020-01-08, 1398/10/18
Registration timing:retrospective
Last update:2020-01-08, 1398/10/18
Update count:0
Registration date
2020-01-08, 1398/10/18
Registrant information
Name
Atefeh Yari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4645 3283
Email address
atefeh.yari.1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intravenous Aminophylline on prevention of headache after spinal anesthesia in patients undergoing elective cesarean section
Public title
The effect of Aminophylline on post-cesarean headache
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women who are able to contribute to the project
Women who are candidates for elective cesarean section
Women being at the age of 15 to 45 years old
Exclusion criteria:
Women with chronic headache history
Women who have coagulopathy or infectious heart disease
Women who have a history of drug abuse
Women with history of using psychotropic drugs
Women who have contraindications for spinal anesthesia, such as high levels of intracranial pressure and lack of satisfaction.
Women who have a known sensitivity to amid drugs
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
While the surgeon and the patient are unaware of the type of injection solution, the injection will be performed by the resident or anesthesia technician. Designer who is completely unaware of injectable drugs will perform all post-injection evaluations.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Moallem Avenue
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.BUMS.REC.1397.242
Health conditions studied
1
Description of health condition studied
postdural puncture headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Headache
Timepoint
1, 8, 16, 24, 36 and 48 hours after surgery
Method of measurement
Headache questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will receive 15 mg of Bupivacaine 0.5% and 250 CC of Dextrose water 5% containing 1.5 mg / kg intravenous Aminophylline.
Category
Prevention
2
Description
Control group: Patients in this group will receive 15 mg of Bupivacaine 0.5% and 250 cc of Dexterose water 5%.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand Valiasr hospital
Full name of responsible person
Atefeh Yari
Street address
No 73; Hafez 6.1; Hafez avenue; Birjand city
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 51 4645 3283
Email
atefeh.yari.1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Atefeh Yari
Street address
No 73; Hafez 6.1; Hafez avenue; Birjand city
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 51 4645 3283
Email
atefeh.yari.1995@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Atefeh Yari
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
No 73; Hafez 6.1; Hafez avenue; Birjand city
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 51 4645 3283
Email
atefeh.yari.1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Bibi Fatemeh Emampour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
No 73; Hafez 6.1; Hafez avenue; Birjand city
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 51 4645 3283
Email
f.emampour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Atefeh yari
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
No 73; Hafez 6.1; Hafez avenue; Birjand city
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 51 4645 3283
Email
atefeh.yari.1995@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available