UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study of the occurrence of post-thoracotomy neuralgia with robotic-assisted thoracic surgery
Acronym	A retrospective study of the occurrence of post-thoracotomy neuralgia with robotic-assisted thoracic surgery
Scientific Title	A retrospective study of the occurrence of post-thoracotomy neuralgia with robotic-assisted thoracic surgery
Scientific Title:Acronym	A retrospective study of the occurrence of post-thoracotomy neuralgia with robotic-assisted thoracic surgery
Region	Japan

Condition
Condition	Post-thoracotomy neuralgia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate retrospectively the frequency of post-thoracotomy neuralgia after robot-assisted thoracic surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of Postoperative Neuralgia in Robot-Assisted and Thoracoscopy-Assisted Thoracic Surgery
Key secondary outcomes	Age,sex,BMI,With or without preoperative analgesics,a history of mental illness,with or without epidural anesthesia,intraoperative remifentanil usage,operating time.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have undergone thoracic surgery
Key exclusion criteria	Non-Open thoracic Surgery Patients
Target sample size	399

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Chikubu
Organization	Chiba university hospital
Division name	Anesthesiology, pain and palliative care medicine
Zip code	260-8677
Address	Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
TEL	043-222-7171
Email	ccpa0908@chiba-u.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Chikubu
Organization	Chiba university hospital
Division name	Anesthesiology,pain and palliative care medicine
Zip code	260-8677
Address	Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
TEL	0432227171
Homepage URL
Email	ccpa0908@chiba-u.jp

Sponsor
Institute	Chiba university hospital
Institute
Department

Funding Source
Organization	Chiba university hospital
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	Chiba university hospital Clinical research center
Address	Inohana1-8-1,Chuo-ku,Chiba-shi
Tel	0432227171
Email	ccpa0908@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

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	399
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	Completed
Date of protocol fixation	2020 Year 11 Month 11 Day
Date of IRB	2020 Year 11 Month 11 Day
Anticipated trial start date	2020 Year 11 Month 11 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective survey

Management information
Registered date	2020 Year 11 Month 24 Day
Last modified on	2022 Year 08 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048556