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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038472
Receipt No. R000043650
Scientific Title Comparative study of epidural and multimodal analgesia groups in postoperative pain management (Randomized controlled trial)
Date of disclosure of the study information 2019/11/07
Last modified on 2019/11/02

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Basic information
Public title Comparative study of epidural and multimodal analgesia groups in postoperative pain management (Randomized controlled trial)
Acronym Comparative study of epidural and multimodal analgesia groups in postoperative pain management
Scientific Title Comparative study of epidural and multimodal analgesia groups in postoperative pain management (Randomized controlled trial)
Scientific Title:Acronym Comparative study of epidural and multimodal analgesia groups in postoperative pain management
Region
Japan

Condition
Condition Lower gastrointestinal surgery
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Establishment of effective and appropriate anesthesia method in ERAS for laparoscopic lower gastrointestinal surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Days until medical recovery
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
Maneuver
Interventions/Control_1 Epidural analgesia : day 0 - day 2
Interventions/Control_2 multimodal analgesia : day 0 - day 2
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 Male and Female
Key inclusion criteria 1. performance status : 0 to 2.
2. Indications for laparoscopic surgery.
3. 20 to 75 years old.
4. Consent has been obtained for participation in this study.
Key exclusion criteria 1. Combined resection of other organs is necessary.
2. An emergency operation case.
3. There is a comorbidity that is a healing delay factor.
4. Not applicable for epidural anesthesia.
5. Not indicated for acetaminophen or fentanest administration.
6. No consent has been obtained for participation in this study.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Kitagawa
Organization Saga university Faculty of Medicine
Division name Department of Surgery
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga, Saga
TEL 0952-31-6511
Email sh2660@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Kitagawa
Organization Saga university Faculty of Medicine
Division name Department of Surgery
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga, Saga
TEL 0952-31-6511
Homepage URL
Email sh2660@cc.saga-u.ac.jp

Sponsor
Institute Department of Surgery, Saga university Faculty of Medicine
Institute
Department

Funding Source
Organization Department of Surgery, Saga university Faculty of Medicine
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 Clinical research center, Saga university hospital
Address 5-1-1 Nabeshima, Saga, Saga
Tel 0952-34-3400
Email sh2660@cc.saga-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
2019 Year 11 Month 07 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2018 Year 07 Month 19 Day
Anticipated trial start date
2018 Year 07 Month 19 Day
Last follow-up date
2022 Year 05 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
2019 Year 11 Month 02 Day
Last modified on
2019 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043650

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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