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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039329
Receipt No. 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 2020/01/30

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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
Email 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
Email s-yonemoto@juntendo.ac.jp

Sponsor
Institute Juntendo University Shizuoka Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 01 Month 21 Day
Date of IRB
2020 Year 02 Month 04 Day
Anticipated trial start date
2020 Year 02 Month 05 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
2020 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044856

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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