UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011122 |
|---|---|
| Receipt number | R000013031 |
| Scientific Title | Thoracic paravertebral block versus epidural anesthesia for postoperative pain management in thoracic surgery |
| Date of disclosure of the study information | 2013/07/10 |
| Last modified on | 2016/12/27 21:17:08 |
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Basic information
Public title
Thoracic paravertebral block versus epidural anesthesia for postoperative pain management in thoracic surgery
Acronym
Thoracic paravertebral block versus epidural anesthesia for postoperative pain management in thoracic surgery
Scientific Title
Thoracic paravertebral block versus epidural anesthesia for postoperative pain management in thoracic surgery
Scientific Title:Acronym
Thoracic paravertebral block versus epidural anesthesia for postoperative pain management in thoracic surgery
Region
| Japan |
Condition
Condition
thoracic surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
postoperative pain management
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual analog scale after surgery
number of dose in intravenous patient controlled analgesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
continuous epidural anesthesia + IV-PCA: group E
Interventions/Control_2
continuous thoracic paravertebral block + IV-PCA group: group T
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
1.ASA class:1.2.3
2.20 years of age or more
3.agree with clinical research
Key exclusion criteria
1.poor understanding for VAS
2.severe cardiac, renal dysfunction
3.severe liver dysfunction
4.poor controll diabetes[HbA1c>8.0, FBS>200mg/dl]
5.having local anesthetic allergy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu UESHIMA |
Organization
Saitama Medical University International Medical Center
Division name
Department of Anesthesiology
Zip code
Address
1397-1 Yamane, Hidaka City, Saitama
TEL
042-984-4111
ueshimhi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Ueshima |
Organization
Saitama Medical University International Medical Center
Division name
Department of Anesthesiology
Zip code
Address
1397-1 Yamane, Hidaka City, Saitama
TEL
042-984-4111
Homepage URL
ueshimhi@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2013 | Year | 07 | Month | 10 | 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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 10 | 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
| 2013 | Year | 07 | Month | 04 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013031
