UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of positioning and bevel direction to post dual puncture headache in spinal anesthesia
Title of the study (Brief title)	The effect of positioning and bevel direction to post dual puncture headache in spinal anesthesia
Region	Japan

Condition
Condition	cesarean section
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	reduce pf PDPH
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	the incidence of PDPH
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	1 day sitting position bevel oriented in a transverse direction
Interventions/Control_2	1day sitting position bevel oriented in a longitudinal to caudad direction
Interventions/Control_3	1day lateral recumbent position bevel oriented in a transverse direction
Interventions/Control_4	1day lateral recumbent position bevel oriented in a longitudinal to caudad direction
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	pregnant woman undergoing cesarean section
Key exclusion criteria	psychiatric disorder migraine headache
Target sample size	80

Research contact person
Name of lead principal investigator	Hiromi Araki
Organization	Suzuki Hospital
Division name	Anesthesiology
Address	1-10-8, Tsukimi-cho, Toyota, Aichi, Japan
TEL	0565-33-8051
Email	hiropan@dg7.so-net.ne.jp

Public contact
Name of contact person	Hiromi Araki
Organization	Suzuki Hospital
Division name	Anesthesiology
Address	1-10-8, Tsukimi-cho, Toyota, Aichi, Japan
TEL	0565-33-8051
Homepage URL
Email	hiropan@dg7.so-net.ne.jp

Sponsor
Institute	Suzuki Hospital Obstetrics
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2016 Year 10 Month 10 Day
Date of closure to data entry	2016 Year 10 Month 15 Day
Date trial data considered complete	2016 Year 10 Month 15 Day
Date analysis concluded	2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 19 Day
Last modified on	2017 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026765