UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021255 |
|---|---|
| Receipt number | R000023082 |
| Scientific Title | Comparison of postoperative pain of rectus sheath block,epidural analgesia in gynaecological cancer surgery |
| Date of disclosure of the study information | 2016/02/29 |
| Last modified on | 2018/09/09 15:38:27 |
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Basic information
Public title
Comparison of postoperative pain of rectus sheath block,epidural analgesia in gynaecological cancer surgery
Acronym
Comparison of postoperative pain of rectus sheath block,epidural analgesia in gynaecological cancer surgery
Scientific Title
Comparison of postoperative pain of rectus sheath block,epidural analgesia in gynaecological cancer surgery
Scientific Title:Acronym
Comparison of postoperative pain of rectus sheath block,epidural analgesia in gynaecological cancer surgery
Region
| Japan |
Condition
Condition
gynaecological cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare postoperative pain of rectus sheath block or epidural analgesia in gynaecological cancer surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
continuous rectus sheath block
Interventions/Control_2
epidural analgesia
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
gynecologic malignant tumor
Key exclusion criteria
chronic pain perfomance state>3
disagree consent of patient and its family
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kuniyoshi Hidkei |
Organization
Tokyo jikei university of kashiwa hospital
Division name
anesthesiology
Zip code
Address
chiba kashiwa kashiwashita 163-1
TEL
04-7164-1111
kuniyoshi0621@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuniyoshi hideki |
Organization
Tokyo jikei university kashiwa of hospital
Division name
anesthesiology
Zip code
Address
chiba kashiwa kashiwashita 163-1
TEL
04-7164-1111
Homepage URL
kuni92@jikei.ac.jp
Sponsor or person
Institute
jikei university kashiwa of hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo jikei university of kashiwa hospital
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
| 2016 | Year | 02 | Month | 29 | 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
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 01 | Day |
Other
Other related information
Evalutating of pain and post nausea and vomitting after postoperative of four,six,
eight,twelve,twenty-four,thirty-six
Management information
Registered date
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2018 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023082
