UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033418 |
|---|---|
| Receipt number | R000038101 |
| Scientific Title | Pain management after free abdominal flap |
| Date of disclosure of the study information | 2018/07/17 |
| Last modified on | 2019/07/18 11:11:04 |
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Basic information
Public title
Pain management after free abdominal flap
Acronym
Pain management after free abdominal flap
Scientific Title
Pain management after free abdominal flap
Scientific Title:Acronym
Pain management after free abdominal flap
Region
| Japan |
Condition
Condition
Patient receiving breast reconstruction with free abdominal flap
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the best pain control method after breast reconstruction with free abdominal flap
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Morphine consumption delivered by the PCA system within 24hours after the surgery
Key secondary outcomes
VAS pain score, blood pressure, tissue oxygenation index using NIRS
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
Continuous rectus sheath block 24hours postoperatively, 0.15% levobupivacaine 5ml/h
Interventions/Control_2
Epidural analgesia 24hours postoperatively, 0.15% levobupivacaine 5ml/h
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patient undergoing unilateral breast reconstruction with free abdominal flap.
Key exclusion criteria
Contraindication for epidural catheterization
Post thoracic spine surgery
Patient with skin disorder at the insertion point of epidural block
Patient with severe hepatic or renal disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Hashimoto |
Organization
Aichi Medical University
Division name
Department of Anesthesiology
Zip code
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
atsushih@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Hashimoto |
Organization
Aichi Medical University
Division name
Department of Anesthesiology
Zip code
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
atsushih@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
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
愛知医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 18 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 18 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 17 | Day |
Last modified on
| 2019 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038101
