UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020367
Receipt No. R000023524
Scientific Title A study of perioperative pain management by ultrasound-guided thoracic paravertebral block method (multiple injection vs. continuous infusion) in video-assisted thoracoscopic surgery
Date of disclosure of the study information 2016/02/01
Last modified on 2016/12/28

* 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 A study of perioperative pain management by ultrasound-guided thoracic paravertebral block method (multiple injection vs. continuous infusion) in video-assisted thoracoscopic surgery
Acronym A study of perioperative pain management by ultrasound-guided thoracic paravertebral block method (multiple injection vs. continuous infusion) in video-assisted thoracoscopic surgery
Scientific Title A study of perioperative pain management by ultrasound-guided thoracic paravertebral block method (multiple injection vs. continuous infusion) in video-assisted thoracoscopic surgery
Scientific Title:Acronym A study of perioperative pain management by ultrasound-guided thoracic paravertebral block method (multiple injection vs. continuous infusion) in video-assisted thoracoscopic surgery
Region
Japan

Condition
Condition video-assisted thoracoscopic surgery for lung tumor
Classification by specialty
Chest surgery Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Thoracic paravertebral block has been performed as a method of perioperative pain management in video-assisted thoracoscopic surgery for lung tumor. By comparing the postoperative analgesic effects of single injection or continuous infusion at the thoracic paravertebral blocks, we consider a safe and appropriate method.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain scales at 24 hours after surgery (Visual analog scale (VAS))
Key secondary outcomes Dose of postoperative morphine
Pain scales after surgery at 0 hours, 2 hours, 48 hours (Numeric Rating Scale (NRS))
The rate of change of NRS in 24 hours 2 hours after surgery
The frequency of complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 continuous infusion (Thoracic paravertebral block)
Interventions/Control_2 single injection[3 points] (Thoracic paravertebral block)
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 Elective video-assisted thoracoscopic surgery for lung tumor
American Society of Anesthesiologists Physical Status Classification 1-2
Preoperative ADL is independence
Written informed consent is provided
Key exclusion criteria Consciousness disabilities
Enough judgment ability nothing
Emergency
ASA-PS over 3
History of hypersensitivity to ropivacaine or amide type local anesthetic
Renal dysfunction (less than eGFR30)
Blood clotting disorder (less than 100,000 platelets/mcl, PT-INR 1.5 or more, less than APTT% 70%)
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimitoshi Nishiwaki
Organization Nagoya University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL 052-744-2340
Email nishi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tasuku Fujii
Organization Nagoya University Hospital
Division name Department of Anesthesiology
Zip code
Address 65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL 052-744-2340
Homepage URL
Email plus9@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Biomedical Regulation, Department of Anesthesiology
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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
Email

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
2016 Year 02 Month 01 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
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 27 Day
Last modified on
2016 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023524

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.