UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Title of the study (Brief title)	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	Katsuhiro Seo
Organization	Kokura memorial hospital
Division name	Department of Anesthesia
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	Tomoharu Shakuo
Organization	Kokura memorial hospital
Division name	Department of Anesthesia
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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