UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002513 |
|---|---|
| Receipt number | R000003075 |
| Scientific Title | Rectus Sheath Block for outpatient laparoscopic ovarian cystectomy: arondomized clinical comparison with or without rectus sheath block |
| Date of disclosure of the study information | 2009/09/17 |
| Last modified on | 2011/03/22 22:01:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Rectus Sheath Block for outpatient laparoscopic ovarian cystectomy: arondomized clinical comparison with or without rectus sheath block
Acronym
Rectus Sheath Block for Laparoscopic Ovarian Cystectomy
Scientific Title
Rectus Sheath Block for outpatient laparoscopic ovarian cystectomy: arondomized clinical comparison with or without rectus sheath block
Scientific Title:Acronym
Rectus Sheath Block for Laparoscopic Ovarian Cystectomy
Region
| Japan |
Condition
Condition
Ovarian Cystectomy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
General anesthesia was considered a good choice for outpatient laparoscopic ovarian cystectomy. However, more painkiller would be required in general anesthesia without regional anesthesia. To obtain more infomation on use of rectus sheath block, we have conducted this prospective, rondomized study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
general anesthesia
Interventions/Control_2
general anesthesia with rectus sheath block
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
Female
Key inclusion criteria
ASA1-2, laparoscopy
Key exclusion criteria
open surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimune Osaka |
Organization
Kitasato Institute Hospital, Kitasato University
Division name
Anesthesiology
Zip code
Address
5-9-1Shirokane, Minato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato Institute Hospital, Kitasato University
Division name
Anesthesiology
Zip code
Address
TEL
Homepage URL
bluesapphire1226@gmail.com
Sponsor or person
Institute
Kitasato Institute Hospital, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
no
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
YES
Study ID_1
09037
Org. issuing International ID_1
Kitasato Institute Hospital, Kitasato University,
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北里大学 北里研究所病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 17 | 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
| 2009 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 17 | Day |
Last modified on
| 2011 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003075
