UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039329 |
|---|---|
| Receipt number | R000044856 |
| Scientific Title | Examination of effectiveness of Paravertebral Block multiple injection for respiratory surgery Comparative study of blinding observers by stratified randomization |
| Date of disclosure of the study information | 2020/02/04 |
| Last modified on | 2021/08/01 09:05:15 |
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Basic information
Public title
Examination of effectiveness of Paravertebral Block multiple injection for respiratory surgery
Comparative study of blinding observers by stratified randomization
Acronym
Examination of effectiveness of Paravertebral Block multiple injection for respiratory surgery
Comparative study of blinding observers by stratified randomization
Scientific Title
Examination of effectiveness of Paravertebral Block multiple injection for respiratory surgery
Comparative study of blinding observers by stratified randomization
Scientific Title:Acronym
Examination of effectiveness of Paravertebral Block multiple injection for respiratory surgery
Comparative study of blinding observers by stratified randomization
Region
| Japan |
Condition
Condition
Respiratory Surgery
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Good postoperative analgesia in respiratory surgery is important for recovery of respiratory function and early ambulation. Until now, epidural anesthesia was considered to be a gold standard, but now paravertebral blocks are performed under ultrasound guidance, and the analgesic effect equivalent to epidural anesthesia has been obtained.
When performing a paravertebral block, the drug is often administered in a single shot between the target ribs, but it is reported that the effect was obtained over a wider area by puncturing multiple times between adjacent ribs and administering the drug Are scattered.
However, there are few reports that widespread use of drugs is effective for postoperative analgesia.
In this study, we considered that performing paravertebral block multiple injection in respiratory surgery is likely to provide better analgesia than performing a single shot, and conducted a randomized controlled trial 48 hours after surgery. The effectiveness of the NRS until the outcome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
single injection of TPVB
Interventions/Control_2
multiple injection of TPVB
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
Patients performing respiratory surgery in the operating room of Juntendo University Shizuoka Hospital
Key exclusion criteria
Patients with simultaneous bilateral surgery
Patients who determine that epidural anesthesia is appropriate for postoperative analgesia
Patients with lesions that are not suitable for puncturing the skin at the puncture site
Patients with a history of allergy to local anesthetics
Patients whose procedure is considered to be dangerous
Patients with renal dysfunction
Patients with a history of asthma attack
In addition, patients who the investigator judged to be inappropriate as subjects
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Yonemoto |
Organization
Juntendo University Shizuoka Hospital
Division name
anesthesiology
Zip code
4102295
Address
1129 Nagaoka, Izunokuni, Shizuoka Prefecture
TEL
0559483111
s-yonemoto@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Yonemoto |
Organization
Juntendo University Shizuoka Hospital
Division name
anesthesiology
Zip code
4102295
Address
1129 Nagaoka, Izunokuni, Shizuoka Prefecture
TEL
0559483111
Homepage URL
s-yonemoto@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Shizuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Shizuoka Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Shizuoka Hospital
Address
1129 Nagaoka, Izunokuni, Shizuoka Prefecture
Tel
0559483111
s-yonemoto@juntendo.ac.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
| 2020 | Year | 02 | Month | 04 | 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
| 2020 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 30 | Day |
Last modified on
| 2021 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044856
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| Registered date | File name |
| Research case data | |
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