UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032267
Receipt No. R000036796
Scientific Title Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study
Date of disclosure of the study information 2018/04/17
Last modified on 2019/05/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study
Acronym Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study
Scientific Title Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study
Scientific Title:Acronym Distribution of injectate administered through a catheter inserted by ultrasound-guided thoracic paravertebral block: A prospective observational study
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To observe distribution of injectate administered through a catheter inserted by performing ultrasound-guided thoracic paravertebral block (TPVB).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes spread pattern of dye in paravertebral space following ultrasound guided paravertebral block
Key secondary outcomes distribution of cutaneous sensory blocakde
Visual Analogue Scale
postoperative use of analgesics
complications regarding block

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria American Society of Anesthesiologists physical status 1-3
Key exclusion criteria contraindications to paravertebral block
Body mass index >35
Allergy to study medications
preoperative opioid use
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University
Division name Operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL 81-853-20-2295
Email ssakura@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University
Division name Operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL 81-853-20-2295
Homepage URL
Email ssakura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

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 Shimane University Hospital, Clinical Trial Review Board
Address 89-1 Enya-cho, Izumo-shi, Shimane, Japan
Tel 0853-20-2515
Email kenkyu@med.shimane-u.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
2018 Year 04 Month 17 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 50
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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 10 Day
Date of IRB
2018 Year 04 Month 10 Day
Anticipated trial start date
2018 Year 04 Month 16 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study was conducted to observe the distribution of injectate administered through a catheter inserted by performing ultrasound-guided thoracic paravertebral block (TPVB) for video assisted thoracoscopic surgery.

Management information
Registered date
2018 Year 04 Month 16 Day
Last modified on
2019 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036796

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.