UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053727 |
|---|---|
| Receipt number | R000061312 |
| Scientific Title | Association of peripheral nerve block under general anesthesia on postoperative nausea and vomiting: a nationwide population-based study |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2024/02/28 12:46:12 |
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Basic information
Public title
Association of peripheral nerve block under general anesthesia on postoperative nausea and vomiting: a nationwide population-based study
Acronym
Association of peripheral nerve block under general anesthesia on postoperative nausea and vomiting: a nationwide population-based study
Scientific Title
Association of peripheral nerve block under general anesthesia on postoperative nausea and vomiting: a nationwide population-based study
Scientific Title:Acronym
Association of peripheral nerve block under general anesthesia on postoperative nausea and vomiting: a nationwide population-based study
Region
| Japan |
Condition
Condition
Patients who underwent GA with PNB during abdominal surgery with those of patients who underwent GA alone.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We used a national Japanese clinical database to evaluate whether there was a difference in the incidence of PONV between patients who underwent GA with PNB and those who underwent GA alone during abdominal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative nausea and vomiting
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who underwent abdominal surgery
Key exclusion criteria
epidural anesthesia
multiple surgical procedure
not extubation
anesthesia duration >1440 h
Target sample size
600000
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Yoshimura |
Organization
Department of Anesthesiology, Ube Industries Central Hospital, Ube, Japan
Division name
Department of Anesthesiology, Ube Industries Central Hospital, Ube, Japan
Zip code
7550151
Address
Department of Anesthesiology, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi 755-0151, Japan
TEL
+81-836-51-9980
manabu-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Yoshimura |
Organization
Ube Industries Central Hospital
Division name
Department of anesthesiology
Zip code
755-0153
Address
750 Nishikiwa, Ube, Yamaguchi 755-0151, Japan
TEL
+81836519968
Homepage URL
manabu-ygc@umin.ac.jp
Sponsor or person
Institute
Ube Industries Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
the Ethics Committee of Ube Industrial Central Hospital
Address
750 Nishikiwa, Ube, Yamaguchi 755-0151, Japan
Tel
+81836519968
hiromi.kato@ube-hp.or.jp
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
| 2024 | Year | 02 | Month | 28 | 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
600000
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
| 2024 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results of this retrospective cohort study conform to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines.7 Further, this study was approved by the Ethics Committee of Ube Industrial Central Hospital (approval number: 153230515; June 12, 2023), which waived the need for informed consent owing to the anonymized nature of the data.
Management information
Registered date
| 2024 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061312
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
