UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Erector Spinae Plane Block Compared with Epidural Analgesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Acronym	Efficacy of Erector Spinae Plane Block Compared with Epidural Analgesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Scientific Title	Efficacy of Erector Spinae Plane Block Compared with Epidural Analgesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Scientific Title:Acronym	Efficacy of Erector Spinae Plane Block Compared with Epidural Analgesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Region	Japan

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

Objectives
Narrative objectives1	The comparison of the clinical effect between the erector spinae plane block and epidural block for the postoperative analgesia in the patients of video-assisted thracoscopic lung resection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain score (Numerical Rating Scale)
Key secondary outcomes	some of the complication

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The administration of the erector spinae plane block for the postoperative analgesia in the patients scheduled for video-assisted thoracic surgery
Interventions/Control_2	The administration of the epidural block for the postoperative analgesia in the patients undergoing video-assisted thoracic surgery
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	ASA Physical status i-iii patients scheduled for a video-assisted thoracic surgery
Key exclusion criteria	Patients who do not consented with this study Patients undergoing anticoagulation therapy Patients of unplanned conversion to thoracotomy
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Marie Middle name Last name Ogawa
Organization	Suwa Red Cross Hospital
Division name	Department of Anesthesiology
Zip code	392-8510
Address	5-11-50 Kogandori, Suwa, Nagano
TEL	0266-52-6111
Email	marie.o@suwa.jrc.or.jp

Public contact
Name of contact person	1st name Marie Middle name Last name Ogawa
Organization	Suwa Red Cross Hospital
Division name	Department of Anesthesiology
Zip code	392-8510
Address	5-11-50 Kogandori, Suwa, Nagano
TEL	0266-52-6111
Homepage URL
Email	marie.o@suwa.jrc.or.jp

Sponsor
Institute	Department of Anesthesiology, Suwa Red Cross Hospital
Institute
Department

Funding Source
Organization	Suwa Red Cross 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	Suwa Red Cross Hospital
Address	5-11-50 Kogandori, Suwa, Nagano
Tel	0266-52-6111
Email	jinji@suwa.jrc.or.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	2019 Year 10 Month 05 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	2019 Year 07 Month 31 Day
Date of IRB	2019 Year 08 Month 29 Day
Anticipated trial start date	2019 Year 10 Month 05 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 03 Day
Last modified on	2020 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043505