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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031428
Receipt No. R000035410
Scientific Title Effect of preemptive duloxetine for postoperative pain
Date of disclosure of the study information 2018/04/11
Last modified on 2018/08/24

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Basic information
Public title Effect of preemptive duloxetine for postoperative pain
Acronym Duloxetine for postoperative pain
Scientific Title Effect of preemptive duloxetine for postoperative pain
Scientific Title:Acronym Duloxetine for postoperative pain
Region
Japan

Condition
Condition Low back pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether preemptive administration of duloxetine reduces postoperative pain.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative pain using visual analogue scale
Key secondary outcomes Consumption of postoperative analgesics

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Duloxetine (40 mg) will be orally administered 2h before surgery, then postoperative pain will be assessed.
Interventions/Control_2 Diazepam (4 mg) will be orally administered 2h before surgery as active placebo group.
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 scheduled to undergo posterior lumbar interbody fusion will be enrolled in this study. The study population included patients aged 20-80 years who are American Society of Anesthesiologists physical status I-II and who agreed to participate in this clinical trial.
Key exclusion criteria 1) Patients who can not use duloxetine
2) Patients who need antipsychotics or antidepressants and who are schizophrenia, bipolar disease, or depression within a year before registration of this study.
3) Patients who needs opioids
4) Patinets who can not agree the protocol.
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Obata
Organization Fukushima Medical University Hospital
Division name Center for Pain Management
Zip code
Address Hikarigaoka 1, Fukushima-city, Fukushima, 960-1295
TEL 024-547-1111
Email obata@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Obata
Organization Fukushima Medical University Hospital
Division name Center for Pain Management
Zip code
Address Hikarigaoka 1, Fukushima-city, Fukushima, 960-1295
TEL 024-547-1111
Homepage URL
Email obata@fmu.ac.jp

Sponsor
Institute Fukushima Medical University Hospital
Institute
Department

Funding Source
Organization Fukushima Medical University Hospital
Organization
Division
Category of Funding Organization Local Government
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 慶友整形外科病院(群馬県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 11 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
2018 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 23 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
2018 Year 02 Month 22 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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