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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007457
Receipt No. R000008779
Scientific Title Clinical evaluation of transversus abdominis plane block and celecoxib after laparoscopic gastrectomy
Date of disclosure of the study information 2012/04/01
Last modified on 2015/04/07

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Basic information
Public title Clinical evaluation of transversus abdominis plane block and celecoxib after laparoscopic gastrectomy
Acronym Evaluation of TAP block and celecoxib after laparoscopic gastrectomy
Scientific Title Clinical evaluation of transversus abdominis plane block and celecoxib after laparoscopic gastrectomy
Scientific Title:Acronym Evaluation of TAP block and celecoxib after laparoscopic gastrectomy
Region
Japan

Condition
Condition Gastric cancer undergoing laparoscopic gastrectomy
Classification by specialty
Gastrointestinal surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate postoperative pain relief after laparoscopic gastrectomy with transversus abdominis plane block and celecoxib
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative pain relief
Key secondary outcomes Adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Intravenous fentanyl analgesia with transversus abdominis plane block and celecoxib
Interventions/Control_2 Intravenous fentanyl analgesia with transversus abdominis plane block
Interventions/Control_3 Intravenous fentanyl analgesia with celecoxib
Interventions/Control_4 Intravenous fentanyl analgesia
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 Male and Female
Key inclusion criteria 1) Gastric cancer undergoing laparoscopic gastrectomy
2) No distant metastasis
3) ASA-PS Class1-2
4) Obtained written informed consent
Key exclusion criteria 1) Patients having severe allergy
2) Case of emergency operation
3) Patients with drug addiction
4) Patients with dementia
5) Patients with severe psychological disease
6) Patients seems inadequate for this study by investigators
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Fukui
Organization Kansai Medical University
Division name Department of Surgery
Zip code
Address 2-3-1, Shinmachi, Hirakata City, Osaka
TEL 072-804-0101
Email fukuiju@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Fukui
Organization Kansai Medical University
Division name Department of Surgery
Zip code
Address 2-3-1, Shinmachi, Hirakata City, Osaka
TEL 072-804-0101
Homepage URL
Email fukuiju@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
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 関西医科大学附属枚方病院 (大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 01 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
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 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
2012 Year 03 Month 06 Day
Last modified on
2015 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008779

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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