UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015362
Receipt number R000017876
Scientific Title The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy
Date of disclosure of the study information 2014/10/07
Last modified on 2017/04/09 11:08:46

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Basic information

Public title

The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy

Acronym

The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy

Scientific Title

The prospective study of the effect of periodic oral NSAIDs for wound pain after hepatectomy

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroya Iida

Organization

Kansai Medical University

Division name

Surgery

Zip code


Address

2-3-1 Shin-machi Hirakata Osaka

TEL

072-804-0101

Email

iidahiro@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroya Iida

Organization

Kansai Medical University

Division name

Surgery

Zip code


Address

2-3-1 Shin-machi Hirakata Osaka

TEL

072-804-0101

Homepage URL


Email

iidahiro@hirakata.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical Univresity

Institute

Department

Personal name



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)



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

2014 Year 10 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

We demonstrated the usefulness of NSAIDs for pain after hepatectomy.

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

Completed

Date of protocol fixation

2014 Year 10 Month 07 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017876


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name