This study is a parallel randomized single-blind clinical trial. It was perform during 12 months in 1390 in 22 Bahman hospital in Gonabad on 160 candidates of cesarean section with spinal anesthesia. For all subjects using anesthesia was sitting position and location of the L3-L4, L4-L5 with a disposable 25-gauge needle with 75 mg lidocaine 5% and 25 mcg of fentanyl. Headache and backache in the first 24 hours and first week after spinal anesthesia were checked. A BSc of Anesthesia filled out the questionnaire. Inclusion criteria were willing to participate in the study, age between 20-40years, havingin cesarean section under spinal anesthesia, physical status be class I and EI according to ASA, no history of psychological disease and no history of migraine or backache. Anesthesia or other surgery during the study were the exclusion criteria. For blindnessthe person who examines and the questioner were not aware of the administration of dexamethasone during spinal anesthesia. Subjects randomly classified into two groups: Intervention group (spinal anesthesia in a sitting position, needle No. 25, with 75 mg lidocaine 5% and 25 micrograms fentanyl and dexamethasone 8 mg intravenous infusion during spinal anesthesia) and Control group (spinal anesthesia in a sitting position, needle No. 25, with 75 mg lidocaine 5% and 25 mcg fentanyl).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201095445N2
Registration date:2012-05-23, 1391/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-23, 1391/03/03
Registrant information
Name
Arash Hamzei
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
arash_hamzei@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Gonabad University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-18, 1390/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dexamethasone on incidence of headache and backache after spinal anesthesia in cesarean section
Public title
Effect of dexamethasone on incidence of headache and backache after spinal anesthesia in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: To be ready to join in trial; age between 20 - 40 years; cesarean section under spinal anesthesia; physical status be class I and EI according to ASA; no history of psychological disease; no history of migraine or backache.
Exclusion criteria: Another anesthesia or any other surgery during the week of study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Ethics Committee of Gonabad University of Medical Sciences
Street address
Dr Mehdizade street, Medical University Campus, Gonabad
City
Gonabad
Postal code
9691793718
Approval date
2011-12-10, 1390/09/19
Ethics committee reference number
6/3/90
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
o29.4
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during pregnancy
Primary outcomes
1
Description
Headache
Timepoint
First 24 hours and first week
Method of measurement
Questionnaire
2
Description
Backache
Timepoint
First 24 hours and first week
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control Group: anesthesia was in sitting position and location of the L3-L4, L4-L5 with a disposable 25-gauge needle with 75 mg lidocaine 5% and 25 mcg of fentanyl.
Category
Treatment - Drugs
2
Description
Intervention group: intraoperative injection of intravenous dexamethasone 8mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital, Gonabad
Full name of responsible person
Dr Arash Hamzei, Anesthesiologist
Street address
Naser Khosro St., Gonabad
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Dr. Mehdizade Street, Medical University Campus, Gonabad
City
Gonabad
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, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Arash Hamzei
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
22 Bahman Hospital, Naser Khosro St., Gonabad
City
Gonabad
Postal code
Phone
+98 53 3725 4222
Fax
Email
arash_hamzei@gmu.ac.ir; arash_hamzei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Arash Hamzei
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
22 Bahman Hospital,Naser Khosro St., Gonabad
City
Gonabad
Postal code
Phone
+98 53 3725 4222
Fax
Email
arash_hamzei@gmu.ac.ir; arash_hamzei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Arash Hamzei
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
22 Bahman Hospital, Naser Khosro St., Gonabad
City
Gonabad
Postal code
Phone
+98 53 3725 4222
Fax
Email
arash_hamzei@gmu.ac.ir; arash_hamzei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)