UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022327
Receipt number R000025722
Scientific Title Effect of perioperative administration of a duloxetine on development of persistent postsurgical pain
Date of disclosure of the study information 2016/05/16
Last modified on 2022/11/22 14:20:30

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Basic information

Public title

Effect of perioperative administration of a duloxetine on development of persistent postsurgical pain

Acronym

Duloxetine on persistent postsurgical pain

Scientific Title

Effect of perioperative administration of a duloxetine on development of persistent postsurgical pain

Scientific Title:Acronym

Duloxetine on persistent postsurgical pain

Region

Japan


Condition

Condition

Patients scheduled to undergo breast, thracic, orthopedic surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine whether perioperative administration of duloxetine influences the development of persistent postsurgical pain.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of persistent postsurgical pain at 3 months after surgery.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Patients receive duloxetine 20 mg orally, 2 h before surgery, 20 mg once daily for the first 6 postoperative days.

Interventions/Control_2

Patients receive placebo orally, 2 h before surgery, once daily for the first 6 postoperative days.

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

Patients scheduled to undergo breast, thoracic, orthopedic surgery.

Key exclusion criteria

Patients who have a pain around surgical site before surgery.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Yuki
Middle name
Last name Yoshiyama

Organization

Shinshu University School of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code

390-0802

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2670

Email

yoshiyama@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Yoshiyama

Organization

Shinshu University School of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code

390-0802

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2670

Homepage URL


Email

yoshiyama@shinshu-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine

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

Shinshu University School of Medicine Medical Ethics Committee

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

Tel

0263-37-2572

Email

mdrinri@shinshu-u.ac.jp


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 05 Month 16 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

Enrolling by invitation

Date of protocol fixation

2016 Year 05 Month 16 Day

Date of IRB

2016 Year 05 Month 10 Day

Anticipated trial start date

2016 Year 05 Month 16 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 16 Day

Last modified on

2022 Year 11 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025722


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name