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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012884
Receipt No. R000014991
Scientific Title Clinical trial for pain relief after complete video-assisted thoracic surgery. Comparison between intercostal nerve block before wound closure followed by oral celecoxib and epidural anesthesia.
Date of disclosure of the study information 2014/02/01
Last modified on 2014/01/17

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Basic information
Public title Clinical trial for pain relief after complete video-assisted thoracic surgery.
Comparison between intercostal nerve block before wound closure followed by oral celecoxib and epidural anesthesia.
Acronym Intercostal nerve block vs. epidural anesthesia in thoracoscopic surgery
Scientific Title Clinical trial for pain relief after complete video-assisted thoracic surgery.
Comparison between intercostal nerve block before wound closure followed by oral celecoxib and epidural anesthesia.
Scientific Title:Acronym Intercostal nerve block vs. epidural anesthesia in thoracoscopic surgery
Region
Japan

Condition
Condition lung
Classification by specialty
Surgery in general Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and the effectiveness of intercostal nerve block before wound closure followed by oral celecoxb.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of adverse ivent.
Scale of post operative pain.
Key secondary outcomes

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
Medicine Maneuver
Interventions/Control_1 Intercostal nerve block before wound closure followed by oral celecoxib.
Interventions/Control_2 Epidural anesthesia.
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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who bear all of the following criterions.
1) Patients who need lung lobectomy for treatment.
2) Regardless of disease.
3) Complete VATS is indicated.
4) Patients 40 years old over and under 80years old.
5) Regardless of sex.
6) Written informed concent was obtained from patient.
Key exclusion criteria Patients who apply any one of following criterions.
1) Patient who has coagulation disorder.
2) Patient who has bleeding tendency.
3) Patient who takes anticoagulant or antiplatelet agent orally.
4) Contraindication to epidural anesthesia.
5) Patient who is allergic to local anesthetic solution
6) Patient who is allergic to celecoxib.
7) Aspirin asthma patients.
8) Peptic ulcer patient.
9) Liver disfunction.
10) Renal disfunction.
11) Sever heart failure.
12) Patients who underwent CABG recently.
13) End of pregnancy.
14) Other inappropriate patiens.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimikazu Hamano
Organization Yamaguchi University Graduate School of Medicine.
Division name Department of Surgery and Clinical Science.
Zip code
Address 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505 Japan.
TEL +81-836-22-2261
Email surg-1@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataro Hayashi
Organization Yamaguchi University Graduate School of Medicine.
Division name Department of Surgery and Clinical Science.
Zip code
Address 1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505 Japan.
TEL +81-836-22-2261
Homepage URL
Email masataro@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine.
Institute
Department

Funding Source
Organization Yamaguchi 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
2014 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
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 02 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
2014 Year 01 Month 17 Day
Last modified on
2014 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014991

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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