UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012884 |
|---|---|
| Receipt number | 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 14:12:17 |
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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
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
masataro@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014991
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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