UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035981 |
|---|---|
| Receipt number | 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 | 2023/08/28 13:16:31 |
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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 | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Sapporo Medical Unoversity School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL
0116112111
atusihon7@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL
0116112111
Homepage URL
atusihon7@gmail.com
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
Sapporo Medical University School of Medicine
Address
Anes. Dept. Minami 1 jo, Nishi 16 cho-me
Tel
0116112111
atusihon7@gmail.com
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
Terminated
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
| 2023 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040983
