UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy
Title of the study (Brief title)	The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy
Region	Japan

Condition
Condition	Patients of open or laparoscopic hepatectomy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is evaluating the early postoperative degree of the wonud pain and quantity of exercise by administering periodic NSAIDs for wound pain after hepatectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. The subjective assessment of the degree of the postoperative wound pain according to VAS (Visual Analog Scale) 2. The objective assessment of the degree of the postoperative wound pain according to PainVision (Measurement device of the quantity of pain) 3. The assessment of the property of postoperative wound pain according to SF-MPQ(Short-Form McGill pain questionnaire) 4. The assessment of the quantity of exercise according to Calorie Counter (pedometer)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Open hepatectomy: Patients are administered 1 tablets of loxoprofen, 3 times a day and 1 tablets of H2 blocker, twice a day from 1 to 10 postoperative days. Laparoscopic hepatectomy: Patients are administered 1 tablets of loxoprofen, twice a day and 1 tablets of H2 blocker, twice a day from 1 to 10 postoperative days.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Inclusion criteria: 1. Patients who agree with written informed consent for the present study 2. Patients who can press a hand switch by sensing the stimulation current
Key exclusion criteria	Exclusion criteria: 1. Patients with impaired skin in the forearm ulnar portion 2. Patients with history of duodenal or stomach ulcer 3. Patients with renal dysfunction (Creatinin 2mg/dl or more) 4. Patients with using electronic implants or other cardiac pacemaker
Target sample size	40

Research contact person
Name of lead principal investigator	Hiroya Iida
Organization	Kansai Medical University
Division name	Surgery
Address	2-3-1 Shin-machi Hirakata Osaka
TEL	072-804-0101
Email	iidahiro@hirakata.kmu.ac.jp

Public contact
Name of contact person	Hiroya Iida
Organization	Kansai Medical University
Division name	Surgery
Address	2-3-1 Shin-machi Hirakata Osaka
TEL	072-804-0101
Homepage URL
Email	iidahiro@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical Univresity
Institute
Department

Funding Source
Organization	N/A
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 07 Day
Anticipated trial start date	2014 Year 10 Month 07 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	Published
URL releasing results
Results	We demonstrated the usefulness of NSAIDs for pain after hepatectomy.
Other related information

Management information
Registered date	2014 Year 10 Month 07 Day
Last modified on	2017 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017876