UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Title of the study (Brief title)	Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Region	Japan

Condition
Condition	an upper abdominal surgery
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In patients undergoing elective upper abdominal surgery in the operating room at Kawasaki University Hospital, a novel disposable PCA device that has just been launched from Daiken Medical Co., Ltd., will be used for epidural postoperative pain control to study the efficacy of the new device.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Wound pain level (resting and moving VAS) Number of requests for PCA and actual number of administrations Total local anesthetic dose Use of rescue drugs (drug, number of administrations and dose)
Key secondary outcomes	Patient backgrounds such as age and sex, etc. Factors related to surgery, such as type, duration and bleeding volume etc. Insertion site and length, etc. in epidural anesthesia

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The novel 200 mL disposable PCA device or will be used as a postoperative PCA pump.
Interventions/Control_2	A mechanical PCA devise will be used as a postoperative PCA pump.
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	Patients aged 20 to 80 years who undergo an elective upper abdominal surgery in the operating room and are at Grade I or II in preoperative patient status (ASA PS) defined by American Society of Anesthesiologist (those who has no significant problem in systemic preoperative status).
Key exclusion criteria	Patients who are considered ineligible for participation in the present study by the attending physician.
Target sample size	60

Research contact person
Name of lead principal investigator	Hideki Nakatsuka
Organization	Kawasaki Medical University
Division name	Department of Anesthesiology & Intensive Care Medicine 2
Address	577 Matsushima, Kurashiki-City, Okayama 701-0192 Japan
TEL	086-462-1111
Email	hideki@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Hideki Nakatsuka
Organization	Kawasaki Medical University
Division name	Department of Anesthesiology & Intensive Care Medicine 2
Address	577 Matsushima, Kurashiki-City, Okayama 701-0192 Japan
TEL	086-462-1111
Homepage URL
Email	hideki@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical University Department of Anesthesiology & Intensive Care Medicine 2
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	川崎医科大学附属病院（岡山県）

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 11 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2012 Year 05 Month 01 Day
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	2011 Year 12 Month 11 Day
Last modified on	2018 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008120