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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035981
Receipt No. R000040983
Scientific Title The usefulness of sphenopalatine ganglion block for postdural puncture headache
Date of disclosure of the study information 2019/02/25
Last modified on 2019/09/29

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Basic information
Public title The usefulness of sphenopalatine ganglion block for postdural puncture headache
Acronym The usefulness of sphenopalatine ganglion block for postdural puncture headache
Scientific Title The usefulness of sphenopalatine ganglion block for postdural puncture headache
Scientific Title:Acronym The usefulness of sphenopalatine ganglion block for postdural puncture headache
Region
Japan

Condition
Condition patients scheduled for epudural analgesia
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The obserbation of the usefulness of sphenopalatine ganglion block for postdural puncture headache
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Headache severity (Numerical rating scale) is ecaluated proior to sphenopalatine ganglion block, 1 hour, 24 hours, and 48 hours after the block.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients are included if they have an American Society of Anesthesiologists physical status 1 to 2 and were scheduled for epidural anesthesia.
Written informed consent was obtained from all study participatns.
Key exclusion criteria The sxclusion criteria were as follows: age younger than 20 years, allergy to local anesthetics, hemmorrhagic, and a surgical hinstory of the nasal cabvity.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Sawada
Organization Sapporo Medical Unoversity School of Medicine
Division name Department of Anesthesiology
Zip code
Address South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL 0116112111
Email atusihon7@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Sawada
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL 0116112111
Homepage URL
Email atusihon7@gmail.com

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization No sources of funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 02 Month 25 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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 22 Day
Date of IRB
2019 Year 02 Month 14 Day
Anticipated trial start date
2019 Year 02 Month 22 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We prospectively administer sphenopalatine ganglion block to patients sufferd from postdural puncture headache. The severities of headache (Numerical rating scale) are recorded prior to sphenopalatine ganglion block, 1 hour, 24 hours, and 48 hours after the procedure. We also recorded the ratio of the relief of headache and recurrence of the headache and the administration of blood patch therapy.

Management information
Registered date
2019 Year 02 Month 23 Day
Last modified on
2019 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040983

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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