UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032471 |
|---|---|
| Receipt number | R000036352 |
| Scientific Title | Ultrasonography-Guided Bilateral Rectus Sheath Block By Anesthesiologist vs Laparoscopic-Guided Bilateral Rectus Sheath Block By Surgeon After Umbilical Hernia Repair |
| Date of disclosure of the study information | 2018/05/04 |
| Last modified on | 2024/10/02 09:34:34 |
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Basic information
Public title
Ultrasonography-Guided Bilateral Rectus Sheath Block By Anesthesiologist vs Laparoscopic-Guided
Bilateral Rectus Sheath Block By Surgeon After Umbilical Hernia Repair
Acronym
Ultrasonography-Guided Bilateral Rectus Sheath Block By Anesthesiologist vs Laparoscopic-Guided
Bilateral Rectus Sheath Block By Surgeon After Umbilical Hernia Repair
Scientific Title
Ultrasonography-Guided Bilateral Rectus Sheath Block By Anesthesiologist vs Laparoscopic-Guided
Bilateral Rectus Sheath Block By Surgeon After Umbilical Hernia Repair
Scientific Title:Acronym
Ultrasonography-Guided Bilateral Rectus Sheath Block By Anesthesiologist vs Laparoscopic-Guided
Bilateral Rectus Sheath Block By Surgeon After Umbilical Hernia Repair
Region
| Japan |
Condition
Condition
Umbilical Hernia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether ultrasound-guided bilateral rectus sheath block by anesthesiologist is more effective than laparoscopic-guided bilateral rectus sheath block by surgeon after umbilical hernia repair
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS after operation
Key secondary outcomes
times of use of rescue drug
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Medicine |
Interventions/Control_1
ultrasound-guided rectus sheath block by anesthesiologist
Interventions/Control_2
laparoscopic-guided rectus sheath block by surgeon
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ASA-PS 1 or 2 undergoing umbilical hernia repair
Key exclusion criteria
patients regularly taking analgesics, patients with dementia, patients with decreased hepatic function, decreased renal function
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Iwasaki |
Organization
Asahikawa Medical Umiversity
Division name
department of anesthesiology
Zip code
0788510
Address
1-1-1, Midorigaokahigashinijou, Asahikawa
TEL
0166-68-2583
hajimedical@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Iwasaki |
Organization
Asahikawa Medical University
Division name
department of anesthesiology
Zip code
078-8510
Address
1-1-1, Midorigaokahigashinijou, Asahikawa
TEL
0166-68-2583
Homepage URL
hajimedical@yahoo.co.jp
Sponsor or person
Institute
Kushiro red cross hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
IRB of Kushiro Red cross hospital
Address
21-14 Shinei-cho, Kushiro, Hokkaido, Japan
Tel
0154-22-7171
nakagoshi@kushiro.jrc.or.jp
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
釧路赤十字病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 04 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036352
