UMIN-CTR Clinical Trial

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

lung cancer

Classification by specialty

Chest surgery

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

the duration of analgesics administration after VATS

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Women's Medical University

Institute

Department

Personal name

Organization

Tokyo Women's Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京女子医科大学

Date of disclosure of the study information

2018

Year

04

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

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 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.

Registered date

2018

Year

04

Month

22

Day

Last modified on

2023

Year

03

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036877