UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The intraoperative analgesic efficacy of transversus abdominis plane block for peritoneal dialysis catheter surgery.
Title of the study (Brief title)	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	Tomoharu Shakuo
Organization	Showa University Northern Yokohama Hospital
Division name	Department of Anesthesia
Address	Chigasaki-chuo, Tsuzuki-ku Yokohama-shi, Kanagawa-ken, 224-8503
TEL	045-949-7000
Email	third.impact@hotmail.co.jp

Public contact
Name of contact person	Tomoharu Shakuo
Organization	Showa University Northern Yokohama Hospital
Division name	Department of Anesthesia
Address	Chigasaki-chuo, Tsuzuki-ku Yokohama-shi, Kanagawa-ken, 224-8503
TEL	045-949-7000
Homepage URL
Email	third.impact@hotmail.co.jp

Sponsor
Institute	Showa University Northern Yokohama Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024006