UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038472 |
|---|---|
| Receipt number | 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 02:20:11 |
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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
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
sh2660@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Saga university Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043650
