UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044856