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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021871
Receipt No. R000025217
Scientific Title prospective randomized study compareing the analgesic efficacy of ultrasound-guided transverse abdominis plane block and local anaesthetic infiltration for laparoscopic cholecystectomy
Date of disclosure of the study information 2016/04/11
Last modified on 2017/10/26

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Basic information
Public title prospective randomized study compareing the analgesic efficacy of ultrasound-guided transverse abdominis plane block and local anaesthetic infiltration for laparoscopic cholecystectomy
Acronym prospective randomized study compareing the analgesic efficacy of ultrasound-guided transverse abdominis plane block and local anaesthetic infiltration for laparoscopic cholecystectomy
Scientific Title prospective randomized study compareing the analgesic efficacy of ultrasound-guided transverse abdominis plane block and local anaesthetic infiltration for laparoscopic cholecystectomy
Scientific Title:Acronym prospective randomized study compareing the analgesic efficacy of ultrasound-guided transverse abdominis plane block and local anaesthetic infiltration for laparoscopic cholecystectomy
Region
Japan

Condition
Condition patients who undergoing laparoscopic cholecystectomy
Classification by specialty
Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 compareing the analgesic efficacy of transverse abdominis plane block and local anesthetic infiltration for laparoscopic cholecystectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes duration of rescue dose
Key secondary outcomes visual analog scale (0,24h)
QOR40

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 local anesthetic infiltration
Interventions/Control_2 ultrasound guided transverse abdominis plane block
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
100 years-old >=
Gender Male and Female
Key inclusion criteria patients who undergoing laparoscopic cholecystectomy
Key exclusion criteria patients who refuse

patients who are occured unexpected change vital and events
Target sample size 80

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Manabu Yoshimura
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Anesthesiology
Zip code
Address Kodacyo 1-1 Shunan 745-8522, Japan
TEL 0834-22-4411
Email manabu-ygc@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Manabu Yoshimura
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Anestheiology
Zip code
Address Kodacho1-1 Shunan745-8522, Japan
TEL 0834-22-4411
Homepage URL
Email manabu-ygc@umin.ac.jp

Sponsor
Institute Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department

Funding Source
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 11 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 Terminated
Date of protocol fixation
2016 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 11 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
2016 Year 04 Month 11 Day
Last modified on
2017 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025217

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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