UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory research of the factor related post thoracic surgery pain
Acronym	Exploratory research of the factor related post thoracic surgery pain
Scientific Title	Exploratory research of the factor related post thoracic surgery pain
Scientific Title:Acronym	Exploratory research of the factor related post thoracic surgery pain
Region	Japan

Condition
Condition	A case in which surgery beyond segmentectomy is performed for lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In addition to the degree of invasiveness by surgery, by considering the individual difference to the subjective sensation of pain, we explore the factors related of postoperative pain
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Before surgery we investigate the individual pain threshold by algometer and the characteristics related to opioid sensitivity, then we identify factors affecting thoracic chronic pain.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Grouped into cases of NRS 4 or more and 3 points or less at 3 months after thoracic surgery, regression analysis of background factors in each group is conducted to investigate factors contributing to postoperative pain. 2)Preoperative PS 0-1. 3)To be able to communicate with each other. 4) In conjunction with thoracic surgery, we plan to use epidural anesthesia in addition to general anesthesia. 5)The thoracotomy method is scheduled to be thoracoscopic or axillary incision thoracotomy, lateral thoracotomy. 6)Patients who can use NSAIDS as a postoperative analgesic. 7) After receiving sufficient explanation for the participation of the research, consent form is obtained with free will by the patient himself / herself or his / her agent after sufficient understanding.
Key exclusion criteria	1)have pain before surgery or use NSAIDS and opioids for pain relief. 2)Have dementia. 3)Patients with other primary organ cancer before thoracic surgery or with recurrence of lung cancer within 3 months after thoracic surgery. 4) Patients who have pain in other areas of surgery. 5)Patients recognized by the attending physician as inappropriate for conducting this study.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Yoshino
Organization	Chiba university
Division name	Department of General Thoracic Surgery, Graduate School of Medicine
Zip code	260-0024
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN
TEL	043-222-7171
Email	koge@office.chiba-u.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Sata
Organization	Chiba universal hospital
Division name	General thoracic surgery
Zip code	260-0024
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN
TEL	043-222-7171
Homepage URL
Email	y.sata.0506@chiba-u.jp

Sponsor
Institute	Chiba university
Institute
Department

Funding Source
Organization	None.
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	Ethics Review Committee, Graduate School of Medicine and School of Medicine, Chiba University
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN
Tel	043-222-7171
Email	inohana-kyodo@chiba-u.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	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 30 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	146
Results	PST and FS were normally distributed among the patients. PST/FS was not significantly associated with BPI scores at each postoperative time-point. The average pain score 1 week after the operation was significantly higher in the thoracotomy group than in the thoracoscopic group (p<0.050). The worst pain scores did not differ between the groups at all the examination periods. PTPS was observed in nine patients, but PST, FS, and surgical procedures were not related to the incidence of PTPS.
Results date posted	2021 Year 01 Month 27 Day
Results Delayed	Delay expected
Results Delay Reason	An article under submission
Date of the first journal publication of results
Baseline Characteristics	Of 146 patients who were enrolled, 100 who met our criteria were analyzed. Pulmonary resection was performed by thoracoscopic surgery in 42 patients and by minimally invasive thoracotomy in 58 patients.
Participant flow	We conducted a single center prospective observational study involving lung cancer patients who underwent anatomical resection.
Adverse events	No adverse events
Outcome measures	Brief pain inventory (BPI), including nine items concerning pain and QOL, was investigated at 1 week, 1 month, and 3 months postoperatively. PST and FS were assessed preoperatively.
Plan to share IPD	Information of individual case data will be shared by publishing paper.
IPD sharing Plan description	We are planning to submitting to the paper in January 2021.

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 17 Day
Date of IRB	2017 Year 05 Month 30 Day
Anticipated trial start date	2017 Year 05 Month 30 Day
Last follow-up date	2018 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study to postoperative pain

Management information
Registered date	2017 Year 05 Month 30 Day
Last modified on	2021 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031589