UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004232
Receipt number R000005088
Scientific Title Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist
Date of disclosure of the study information 2010/09/18
Last modified on 2010/09/18 17:35:51

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Basic information

Public title

Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist

Acronym

Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist

Scientific Title

Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist

Scientific Title:Acronym

Preventing postoperative pain: Effect of Neurokinin-1 receptor antagonist

Region

Japan


Condition

Condition

postoperative pain

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluating the efficacy and tolerability of aprepitant for theprevention of the postoperative pain.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

postoperative pain and morphine consumption

Key secondary outcomes

frequency of the PONV and pruritus


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients received abdominal surgery of gynaecology are randomly assigned aprepitant group to Control group. On the day of surgery, aprepitant group takes orally Aprepitant (125mg) at 2 hours before induction of anesthesia.

Interventions/Control_2

Control group akes orally placebo (lactose powder capsule; 40 mg) at 2 hours before induction of anesthesia.

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

Patients are 20-65 years old who met the criteria of the American Society of Anesthesiologists physical status of 1-2 and undergo abdominal surgery. Having written informed consent.

Key exclusion criteria

Patiens are excluded the criteria of the American Society of Anesthesiologists physical status of over 3 and have the history of hypersensitivity for aprepitant.

Target sample size

95


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Kawano

Organization

Kochi Medical School Hospital

Division name

Anesthesiology

Zip code


Address

Kohasu, Oko, Nankoku City, Kochi 783-8505, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kochi Medical School Hospital

Division name

Anesthesiology

Zip code


Address

Kohasu, Oko, Nankoku City, Kochi 783-8505, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Anesthesiology, Kochi Medical School Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2010 Year 09 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Preinitiation

Date of protocol fixation

2010 Year 09 Month 18 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 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

2010 Year 09 Month 18 Day

Last modified on

2010 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005088


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name