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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032342
Receipt No. R000036877
Scientific Title Postoperative pain after video-assisted thoracic surgery (VATS) from the viewpoint of use of analgesics: A retrospective study
Date of disclosure of the study information 2018/04/23
Last modified on 2020/02/28

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Basic information
Public title Postoperative pain after video-assisted thoracic surgery (VATS) from the viewpoint of use of analgesics: A retrospective study
Acronym Postoperative pain after VATS: A retrospective study
Scientific Title Postoperative pain after video-assisted thoracic surgery (VATS) from the viewpoint of use of analgesics: A retrospective study
Scientific Title:Acronym Postoperative pain after VATS: A retrospective study
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to evaluate the time course of postoperative pain after VATS up to 180 days postoperatively by analyzing the administration duration of analgesics
Basic objectives2 Others
Basic objectives -Others To clarify factors that influence the time course of analgesic use rate after VATS
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes the duration of analgesics administration after VATS
Key secondary outcomes

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 Potential participants were patients aged 20 years or older who underwent lung resection for lung cancer by VATS under general anesthesia alone, and was given an intravenous patient-controlled analgesia (IVPCA) for pain management in the postoperative acute phase in the Tokyo Women's Medical University Hospital between January 2013 and December 2017.
Key exclusion criteria Of the following patients, those judged inappropriate from the contents of the medical record were excluded from the subject patients.
1. Patients who had been taking the investigated analgesics prior to surgery;
2. Patients with confirmed pleural dissemination or chest wall invasion during surgery;
3. Patients who underwent reoperation or chest drainage for postoperative complications;
4. Patients in whom pain evaluation became difficult due to worsening of the general condition;
5. Patients who were prescribed analgesics for purposes other than postoperative analgesia during the observation period and whose duration of analgesic use was determined to be difficult to calculate;
6. Patients who were prescribed analgesics at other hospitals during the observation period and whose duration of analgesic use was determined to be difficult to calculate.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Ozaki
Organization Tokyo Womens' Medical University
Division name Department of Anesthesiology
Zip code 162-8666
Address 8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
TEL 03-3353-8111
Email ozaki.makoto@twmu.ac.jp

Public contact
Name of contact person
1st name Katsuyuki
Middle name
Last name Yamagata
Organization Tokyo Womens' Medical University
Division name Department of Anesthesiology
Zip code 162-8666
Address 8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
TEL 03-3353-8111
Homepage URL
Email yamagata.katsuyuki@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Womens' Medical University
Address 8-1 Kawada-cho, Shinuku-ku, Tokyo 162-8666, Japan
Tel 03-3353-8111
Email rinri.bm@twmu.ac.jp

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 東京女子医科大学

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 23 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
2018 Year 04 Month 22 Day
Date of IRB
2018 Year 04 Month 13 Day
Anticipated trial start date
2018 Year 04 Month 24 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective study
Potential participants were patients aged 20 years or older who underwent lung resection for lung cancer by VATS under general anesthesia alone, and was given an intravenous patient-controlled analgesia (IVPCA) for pain management in the postoperative acute phase in the Tokyo Women's Medical University Hospital between January 2013 and December 2017.

Management information
Registered date
2018 Year 04 Month 22 Day
Last modified on
2020 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036877

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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