UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021025 |
|---|---|
| Receipt number | R000024006 |
| Scientific Title | The intraoperative analgesic efficacy of transversus abdominis plane block for peritoneal dialysis catheter surgery. |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2016/12/12 12:08:51 |
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Basic information
Public title
The intraoperative analgesic efficacy of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Acronym
The intraoperative analgesic efficacy of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Scientific Title
The intraoperative analgesic efficacy of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Scientific Title:Acronym
The intraoperative analgesic efficacy of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Most patients undergoing the peritoneal dialysis(PD) catheterization are in frail health; therefore, the operation is performed not under general anesthesia but under infiltration anesthesia. We use transversus abdominis plane block(TAPB) after 2014. As TAPB provides effective analgesia to the anterior abdominal wall, it also works for the pain of PD surgery. The purpose of this study to find out the analgesic efficacy of TAPB for PD surgery: Retrospective analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
verbal numerical rating score(VNRS)
visual analogue scale(VAS)
in the first 24 hours after a surgery
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Male and Female
Key inclusion criteria
The patients awaiting the peritoneal dialysis surgery in ASA Physical Status from 1 to 3/Provided written informed consent to undergo the procedure.
Key exclusion criteria
Patients who cannot communicate/Patients who are judged to be inappropriate for this study by doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoharu Shakuo |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesia
Zip code
Address
Chigasaki-chuo, Tsuzuki-ku Yokohama-shi, Kanagawa-ken, 224-8503
TEL
045-949-7000
third.impact@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoharu Shakuo |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesia
Zip code
Address
Chigasaki-chuo, Tsuzuki-ku Yokohama-shi, Kanagawa-ken, 224-8503
TEL
045-949-7000
Homepage URL
third.impact@hotmail.co.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Northern Yokohama Hospital
Organization
Division
Category of Funding Organization
Profit organization
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 | 25 | 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
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The analgesic effect was better in TAPB group than in local anesthesia group.
Management information
Registered date
| 2016 | Year | 02 | Month | 15 | Day |
Last modified on
| 2016 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024006
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