UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022729 |
|---|---|
| Receipt number | R000026183 |
| Scientific Title | A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Analgesia |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2016/09/19 01:35:08 |
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Basic information
Public title
A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Analgesia
Acronym
A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Alalgesia
Scientific Title
A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Analgesia
Scientific Title:Acronym
A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Alalgesia
Region
| Japan |
Condition
Condition
gynecologic laparoscopic surgery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare transverse abdominal plane block and rectus sheath block in terms of effectiveness for postoperative analgesia after gynecologic laparoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual analog scale scores recorded at 2,6,12 amd 24h after surgery
Key secondary outcomes
frequency of analgesic used after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Ultrasound guided transverse abdominal plane block
Interventions/Control_2
Ultrasound guided 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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Scheduled operation of gynecologic laparoscopic surgery
2)Written informed concent
Key exclusion criteria
1)Emergency surgery
2)Abdominal surgery
3)Allergy of study medicine
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Shimakawa |
Organization
Saga-Ken medical centre koseikan
Division name
anesthesiology
Zip code
Address
400, Nakabaru,Kase,Saga,Japan
TEL
0952242171
shimakawa-y@koseikan.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Shimakawa |
Organization
Saga-Ken medical centre koseikan
Division name
anesthesiology
Zip code
Address
400,Nakabaru,Kase,Saga,Japam
TEL
0952242171
Homepage URL
shimakawa-y@koseikan.jp
Sponsor or person
Institute
Saga-Ken medical centre koseikan
Institute
Department
Personal name
Funding Source
Organization
Saga-Ken medical centre koseikan
Organization
Division
Category of Funding Organization
Local Government
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 | 06 | Month | 15 | 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
| 2016 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 15 | 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
| 2016 | Year | 06 | Month | 14 | Day |
Last modified on
| 2016 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026183
