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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034960
Receipt No. R000039864
Scientific Title Investigation of the influence of analgesic medication during surgery on postoperative pain
Date of disclosure of the study information 2018/11/26
Last modified on 2018/11/21

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Basic information
Public title Investigation of the influence of analgesic medication during surgery on postoperative pain
Acronym Analgesic medication and postoperative pain
Scientific Title Investigation of the influence of analgesic medication during surgery on postoperative pain
Scientific Title:Acronym Analgesic medication and postoperative pain
Region
Japan

Condition
Condition General anesthetic patient
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate whether opioid administered during surgery causes postoperative hyperalgesia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative hyperalgesia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 moderate dose of opioid administration during operation
Interventions/Control_2 low dose of opioid administration during operation
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
60 years-old >
Gender Female
Key inclusion criteria Benign Gynecological Disease
Key exclusion criteria Severe systemic disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiko Aoe
Organization Teikyo University
Division name Chiba Medical Center, Pain Center
Zip code
Address 3426-3 Anesaki, Ichihara City, Chiba 299-0111, Japan
TEL 0436-62-1211
Email tomohikoA@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiko Aoe
Organization Teikyo University
Division name Chiba Medical Center, Pain Center
Zip code
Address 3426-3 Anesaki, Ichihara City, Chiba 299-0111, Japan
TEL 0436-62-1211
Homepage URL
Email tomohikoA@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Teikyo University
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 帝京大学ちば総合医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 26 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
2018 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 26 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 11 Month 21 Day
Last modified on
2018 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039864

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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