UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027556 |
|---|---|
| Receipt number | R000031589 |
| Scientific Title | Exploratory research of the factor related post thoracic surgery pain |
| Date of disclosure of the study information | 2017/05/30 |
| Last modified on | 2021/01/27 11:30:02 |
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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
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
y.sata.0506@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031589
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