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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025224
Receipt No. 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

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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
Email 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
Email third.impact@hotmail.co.jp

Sponsor
Institute kokura memorial hospital
Institute
Department

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
Email

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
URL(English) https://upload.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


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