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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031275
Receipt No. R000035708
Scientific Title Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/13

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Basic information
Public title Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit
Acronym Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit
Scientific Title Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit
Scientific Title:Acronym Evaluation of postoperative pain after complete video-assisted thoracic surgery in intensive care unit
Region
Japan

Condition
Condition Surgical patients who underwent video-assisted thoracic surgery
Classification by specialty
Chest surgery Anesthesiology Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to evaluate severity of postoperative pain and to determine the optimal method in analgesia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Time from ICU admission to first administration of additional analgesic
Key secondary outcomes Dose of opioids
Dose of NSAIDs
Use of epidural anesthesia
Use of local filtration anesthesia
Use of intercostal blockade
Pain severity (numeric rating scale)
Incidence of PONV

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_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

Not applicable
Gender Male and Female
Key inclusion criteria Surgical patients who underwent video-assisted thoracic surgery
Key exclusion criteria Liver dysfunction
Renal dysfunction
Communication disorder with psychiatric disease
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigekazu Sugino
Organization Tohoku University
Division name Department of Anesthesiology and Perioperative Medicine
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL 0227177321
Email sugino@ruby.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigekazu Sugino
Organization Tohoku University
Division name Department of Anesthesiology and Perioperative Medicine
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL 0227177321
Homepage URL
Email sugino@ruby.ocn.ne.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Self funding
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
2018 Year 03 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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will asign 350 patients to the trial.

Management information
Registered date
2018 Year 02 Month 13 Day
Last modified on
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035708

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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