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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012010
Receipt No. R000004892
Scientific Title study of postoperative pain relief by infiltration analgesia using multihole catheter
Date of disclosure of the study information 2013/10/11
Last modified on 2016/04/10

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Basic information
Public title study of postoperative pain relief by infiltration analgesia using multihole catheter
Acronym study of postoperative pain relief by infiltration analgesia using multihole catheter
Scientific Title study of postoperative pain relief by infiltration analgesia using multihole catheter
Scientific Title:Acronym study of postoperative pain relief by infiltration analgesia using multihole catheter
Region
Japan

Condition
Condition Postoperative pain
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the clinical effect of continuous infiltration and regional analgesia compared with conventional technique on postoperative pain relief
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analogue pain scale
Amount of supplemental anesthetics
Side effects of anesthetics
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 continuous infiltration analgesia
Interventions/Control_2 transversus abdominis plane block
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
85 years-old >
Gender Female
Key inclusion criteria Gynecological laparotomy
Key exclusion criteria severe systemic complication
coagulopaphy
contraindication of local anesthetics, opioids and NSAIDs
Target sample size 174

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihisa Hotta
Organization Jichi Medical University
Division name Department of Anesthesiology
Zip code
Address Yakushiji 3311-1, Shimotsuke, Tochigi
TEL 0285-44-2111
Email hottak@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihisa Hotta
Organization Jichi Medical University
Division name Department of Anesthesiology
Zip code
Address Yakushiji 3311-1, Shimotsuke, Tochigi
TEL 0285-44-2111
Homepage URL
Email hottak@jichi.ac.jp

Sponsor
Institute Jichi Medical University Department of Anesthesiology
Institute
Department

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
2013 Year 10 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially 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 Main results already published
Date of protocol fixation
2009 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 07 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
2013 Year 10 Month 10 Day
Last modified on
2016 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004892

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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