UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025224 |
|---|---|
| Receipt number | R000028921 |
| Scientific Title | Efficacy and safety of transversus abdominis plane block for peritoneal dialysis catheter surgery. |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2016/12/07 12:52:09 |
* 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
Efficacy and safety of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Acronym
Efficacy and safety of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Scientific Title
Efficacy and safety of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Scientific Title:Acronym
Efficacy and safety of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A few clinical studies on the efficacy of infiltration anesthesia associated with transversus abdominis plane block(TAPB) for peritoneal dialysis(PD) catheterization have been reported. The purpose of this study to find out the postoperative analgesic efficacy of TAPB for PD surgery: Prospective analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy: area under curve(AUC) of visual analogue scale (VAS) 0, 1, 3, 6 and 24 hours after the operation
Key secondary outcomes
Postoperative VAS(0, 1, 3, 6 and 24 hours)
Additional dosage of infiltration anesthetics during the operation
Total dosage of local anesthetics
Operation time
Postoperative analgesics consumption
Pain days after the operation
RASS during the operation(entering and leaving, every 30 minutes)
Incidence of local anesthetic systemic toxicity
Incidence of postoperative and intraoperative nausea and vomiting
Incidence of cease of operation by patient's pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ultrasound guided transverse abdominis plane block with 0.75% ropivacaine 14mL, 1% mepivacaine 14mL and saline 14mL is performed before infiltration anesthesia.
Interventions/Control_2
Infiltration anesthesia alone
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
Male and Female
Key inclusion criteria
The patients awaiting the peritoneal dialysis surgery in ASA Physical Status from 1 to3/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
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Seo |
Organization
Kokura memorial hospital
Division name
Department of Anesthesia
Zip code
Address
3-2-1, asano, kokurakita-ku, kitakyushu-shi, Fukuoke-ken
TEL
+81-93-511-2000
third.impact@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoharu Shakuo |
Organization
Kokura memorial hospital
Division name
Department of Anesthesia
Zip code
Address
3-2-1, asano, kokurakita-ku, kitakyushu-shi, Fukuoke-ken
TEL
+81-93-511-2000
Homepage URL
third.impact@hotmail.co.jp
Sponsor or person
Institute
kokura memorial hospital
Institute
Department
Personal name
Funding Source
Organization
kokura memorial hospital
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | 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
Management information
Registered date
| 2016 | Year | 12 | Month | 12 | Day |
Last modified on
| 2016 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028921
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
