UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035661 |
|---|---|
| Receipt number | R000040623 |
| Scientific Title | The effect of postoperative analgesia for post operative oxygenation in patients with interstitial pneumonia undergoing surgical biopasy |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2019/11/25 20:45:51 |
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Basic information
Public title
The effect of postoperative analgesia for post operative oxygenation in patients with interstitial pneumonia undergoing surgical biopasy
Acronym
The effect of postoperative analgesia for post operative oxygenation in patients with interstitial pneumonia undergoing surgical biopasy
Scientific Title
The effect of postoperative analgesia for post operative oxygenation in patients with interstitial pneumonia undergoing surgical biopasy
Scientific Title:Acronym
The effect of postoperative analgesia for post operative oxygenation in patients with interstitial pneumonia undergoing surgical biopasy
Region
| Japan |
Condition
Condition
Inetrstitial Pneumonia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is investigating the association betweeen postoperative analgesia (epidural anesthesia or intercostal nerve block) and postoperative oxygenation in patients with interstitial pneumonia undergoing surgical biopsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of oxygen independent patients in each analgesia group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Epidural anesthesia with continuous infusion of 0.2% ropivacaine.
Interventions/Control_2
Intra operative sigle shot 0.375% ropivacaine as intercostal nerve block and postoperative continuous intravenous infusion of fentanyl.
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 undergoing surgical lung biopsy for interstitial pneumonia, who admit to ICU after the opration.
Key exclusion criteria
Exclusion criteria:1) Patients who have contraindications to epidural anesthesia, 2) Patients underwent home oxygen therapy before the operation, 3) Patients who admit to ICU under tracheal intubation and mechanical ventilation.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Gamo |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Anesthesiology
Zip code
Address
6-16-1, Tomiokahigashi, Kanazawa-ku Yokohama-shi, Kanagawa, Japan
TEL
045-701-9581
gamou@kanagawa-junko.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuhiro Yamamoto |
Organization
Yokohama City University
Division name
Department of Anesthesiology
Zip code
Address
3-9, Fukuura, Kanazawa-ku Yokohama-shi, Kanagawa, Japan
TEL
045-787-2918
Homepage URL
natsuyamamo@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
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
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
神奈川県立循環器呼吸器病センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | 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 | 01 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040623
| 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 |
