UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023223 |
|---|---|
| Receipt number | R000026765 |
| Scientific Title | The effect of positioning and bevel direction to post dual puncture headache in spinal anesthesia |
| Date of disclosure of the study information | 2016/07/20 |
| Last modified on | 2017/01/20 01:53:59 |
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Basic information
Public title
The effect of positioning and bevel direction to post dual puncture headache in spinal anesthesia
Acronym
The effect of positioning and bevel direction to post dual puncture headache in spinal anesthesia
Scientific Title
The effect of positioning and bevel direction to post dual puncture headache in spinal anesthesia
Scientific Title:Acronym
The effect of positioning and bevel direction to post dual puncture headache in spinal anesthesia
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Hiromi Araki |
Organization
Suzuki Hospital
Division name
Anesthesiology
Zip code
Address
1-10-8, Tsukimi-cho, Toyota, Aichi, Japan
TEL
0565-33-8051
hiropan@dg7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Araki |
Organization
Suzuki Hospital
Division name
Anesthesiology
Zip code
Address
1-10-8, Tsukimi-cho, Toyota, Aichi, Japan
TEL
0565-33-8051
Homepage URL
hiropan@dg7.so-net.ne.jp
Sponsor or person
Institute
Suzuki Hospital
Obstetrics
Institute
Department
Personal name
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
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026765
