UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028338 |
|---|---|
| Receipt number | R000031194 |
| Scientific Title | Comparison of analgesic effect between epidural anesthesia and breast block for the thoracic surgery patients. |
| Date of disclosure of the study information | 2017/08/10 |
| Last modified on | 2019/08/14 12:47:33 |
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Basic information
Public title
Comparison of analgesic effect between epidural anesthesia and breast block for the thoracic surgery patients.
Acronym
Examination of the analgesic method for the thoracic surgery operation.
Scientific Title
Comparison of analgesic effect between epidural anesthesia and breast block for the thoracic surgery patients.
Scientific Title:Acronym
Examination of the analgesic method for the thoracic surgery operation.
Region
| Japan |
Condition
Condition
Lung cancer, pulmonary metastasis, pulmonary benign tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of the valid sedative method after the breast procedures for the patients during an anticoagulant therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
NRS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) 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
peripheral nerve block
We detain peridural catheter before induction of anaesthesia in all cases.
We introduce a general anesthesia and perform a nerve block after having established an operative position.
As supporting analgesia, a fentanyl constant infusion is provided and uses the epidural anesthesia only at pain control distress after the next day.
We measure as a pain evaluation using nrs for 2, 4, 6,12,24,36,48 hours after surgery.
We measure before and after an operation about the presence or absence of stress hormone discharge in nerve block group.
Interventions/Control_2
epidulal
We implant peridural catheter similar to nerve block group and introduce a general anesthesia.
We start the administration of local anesthetics at peridural catheter during an operation.
The supporting analgesic is carried out similar to nerve block group.
The pain evaluation is carried out similar to nerve block group, too.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
video-assisted mini-thoracotomy
Key exclusion criteria
drug allergy
bleeding tendency
intenshion of the patient
analgesic addict
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masako Yamamoto |
Organization
Kawasaki Medical School
Division name
anesthesiology
Zip code
Address
577Matushima Kurashiki-City Okayama
TEL
086-464-1111
masakok319791008@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masako Yamamoto |
Organization
Kawasaki Medical School
Division name
anesthesiology
Zip code
Address
577Matushima Kurashiki-City Okayama
TEL
086-4-464-1111
Homepage URL
masakok319791008@yahoo.co.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
| 2017 | Year | 08 | 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
16
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
| 2017 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 23 | Day |
Last modified on
| 2019 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031194
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