Purpose: Postdural puncture headache (PDPH) is the most common postoperative complication of spinal anesthesia. The actual mechanism producing the PDPH remains unclear. Numerous studies on its pathophysiology, prevention and treatment have been published. The objective of our study was to evaluate the effect of prophylactic administration of injection of intratechal normal saline in decreasing postdural puncture headache.
Methods: One hundred healthy women (ASA physical status I) with ages between 18-35 years scheduled for elective term cesarean delivery under spinal anesthesia. Subjects were randomly divided into two equal groups. 2.5 ml (12.5 mg) hyperbaric bupivacaine was injected in group C as a control group and the injection of 5mL intrathecal normal saline and then injection of 2.5 mL (12.5 mg) hyperbaric bupivacaine was performed in group S as a study group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803051951N1
Registration date:2011-05-08, 1390/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-08, 1390/02/18
Registrant information
Name
Nasrin Faridi Tazeh-kand
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
nfaridi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-04-01, 1388/01/12
Expected recruitment end date
2009-12-31, 1388/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Injection of intratechal normal saline in decreasing postdural puncture headache (PDPH)
Public title
Postdural puncture headache and normal saline
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: healthy women (ASA physical status I) with ages between 18-35 years scheduled for elective term cesarean delivery under spinal anesthesia.
Exclusion criteria: Parturient were excluded from the study if they had preexisting hypertension, diabetes mellitus, chronic headache, history of previous PDPH, number of lumbar puncture attempts more than two and contraindication to spinal anesthesia.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2011-05-01, 1390/02/11
Ethics committee reference number
90/ ص/210/130
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
existence of headache and severity
Timepoint
12, 24 and 48 hours and 3 rd and 7th days after cesarean section
Method of measurement
interview
Secondary outcomes
1
Description
complications
Timepoint
any time
Method of measurement
asking patients
Intervention groups
1
Description
After obtaining free-flowing cerebrospinal fluid, the injection of 5mL intrathecal normal saline and then injection of 2.5 mL (12.5 mg) hyperbaric bupivacaine was performed in group S as a study group.
Category
Prevention
2
Description
After obtaining free-flowing cerebrospinal fluid, 2.5 ml (12.5 mg) hyperbaric bupivacaine was injected in group C as a control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Nasrin Faridi Tazeh-kand
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical scinces/Vice chancellor for research
Full name of responsible person
Dr Akbar Fotoohi
Street address
Vice chansellor for research, Tehran University of Medical scinces
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical scinces/Vice chancellor for research