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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033418
Receipt No. 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

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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
Email 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
Email atsushih@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038101

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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