A clinical trial comparing administration versus non-administration of intravenous Dexamethasone on the incidence of headache after spinal anesthesia in women undergoing caesarean section
This randomized, double-blind clinical trial examined the effects of intravenous dexamethasone on the incidence of headache after spinal anesthesia in candidates of cesarean section. This study is in the second phase of clinical trials and was conducted on 104 patients. The inclusion criteria consisted of age from 15 to 45 years; pregnant women of Class 1 and 2 with uncomplicated term pregnancy according to the physical status classification by the American Society of Anesthesiologists; and candidature for cesarean section. The study was performed in Valiasr Hospital of Birjand. All the patients underwent spinal anesthesia using quince 25 needle with 0.5 percent 12-15 milligram bupivacaine (topical anesthetic). After spinal anesthesia, the patients were allocated into control and intervention groups (n= 52 per group) via simple random allocation method. In the intervention group, 8 milligram intravenous dexamethasone was injected. In the control group, 2 cc distilled water or normal saline was injected. Forty-eight hours after the operation, the severity of headache was studied and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080117756N22
Registration date:2017-08-30, 1396/06/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-30, 1396/06/08
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery for Research, Birjand University of Medical Sciences
Expected recruitment start date
2013-08-16, 1392/05/25
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing administration versus non-administration of intravenous Dexamethasone on the incidence of headache after spinal anesthesia in women undergoing caesarean section
Public title
The effects of intravenous Dexamethasone on headache
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age from 15 to 45 years; pregnant woman of Class 1 and 2 with uncomplicated term pregnancy according to the physical status classification by the American Society of Anesthesiologists; candidature for cesarean section surgery.
Exclusion criteria: Prohibition of spinal anesthesia (for example, coagulation disorders, peripheral neuropathy, infection of the needle insertion site, and spinal cord disorders); history of headache, migraine, and hypertension (as in eclampsia and preeclampsia).
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Both the data collectors and the patients were uninformed of the allocated groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice-chancellery for Research, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2013-08-12, 1392/05/21
Ethics committee reference number
Ir.bums.1394.403
Health conditions studied
1
Description of health condition studied
Headache
ICD-10 code
O89.4
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during the puerperium
Primary outcomes
1
Description
Headache severity
Timepoint
48 hours after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control Group (distilled water or normal saline): All the patients underwent spinal anesthesia using quince 25 needle with 0.5 percent 12-15 milligram bupivacaine (topical anesthetic). Then, 2 cc distilled water or normal saline was injected.
Category
Prevention
2
Description
Intervention Group (intravenous dexamethasone): All the patients underwent spinal anesthesia using quince 25 needle with 0.5 percent 12-15 milligram bupivacaine (topical anesthetic). Afterwards, 8 milligram intravenous dexamethasone was injected intravenously after spinal anesthesia.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr. Bibi Fatemeh Shakhs Emampour
Street address
Ghafari Street,
City
Birjand,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery for Research and Technology of Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Vice-chancellor for Research, Birjand University of Medical Sciences, Ayatollah Ghafari Street,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery for Research and Technology of Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Bibi Fatemeh Shakhs Emampour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street,
City
Birjand,
Postal code
Phone
+98 56 3239 5600
Fax
Email
f.emepour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Bibi Fatemeh Shakhs Emampour
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street,
City
Birjand,
Postal code
Phone
+98 56 3239 5600
Fax
Email
f.emepour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 562395680
Fax
Email
roozgar@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)