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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019816
Receipt No. R000022717
Scientific Title Pre-heating effect of mepivacaine on initiation of epidural analgesia.
Date of disclosure of the study information 2015/11/17
Last modified on 2017/05/01

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Basic information
Public title Pre-heating effect of mepivacaine on initiation of epidural analgesia.
Acronym Pre-heating effect of mepivacaine
Scientific Title Pre-heating effect of mepivacaine on initiation of epidural analgesia.
Scientific Title:Acronym Pre-heating effect of mepivacaine
Region
Japan

Condition
Condition Upper abdominal surgery
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate whether the temperature of mepivacaine used as a test injection during epidural puncture affects analgesic area.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analgesic area
Key secondary outcomes Hypotension after induction of anesthesia
Postoperative neurological symptoms

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Injection of 3ml mepivacaine at 20 degree Celsius during epidural puncture before surgery.
Interventions/Control_2 Injection of 3ml mepivacaine at 37 degree Celsius during epidural puncture before surgery.
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 for elective upper abdominal surgery.
Written informed consent will be obtained from all subjects.
Key exclusion criteria Emergency surgery
Ileus
ASA physical status >= 4
Patients with peripheral or central nerve disorder
WBC>=10000/&micro;l, CRP>=0.3
PT-INR>1.2, APTT-T>41, Plt<10000/&micro;l
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumio Hoka
Organization Kyushu University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan
TEL +81926425714
Email shoka@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryohei Miyazaki
Organization Kyushu University
Division name Operating Rooms
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan
TEL +81926425714
Homepage URL
Email miyaryou@kuaccm.med.kyushu-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Critical Care Medicine, Kyushu University
Institute
Department

Funding Source
Organization None
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
2015 Year 11 Month 17 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
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
2015 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 15 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
2015 Year 11 Month 17 Day
Last modified on
2017 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022717

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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