UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of ultrasound-guided paravertebral block and erector spinae plane block in postoperative analgesia after video-assisted thoracoscopic surgery: a prospective, randomized, non-inferiority trial.
Acronym	A prospective study of ultrasound-guided erector spinae plane block.
Scientific Title	Comparison of ultrasound-guided paravertebral block and erector spinae plane block in postoperative analgesia after video-assisted thoracoscopic surgery: a prospective, randomized, non-inferiority trial.
Scientific Title:Acronym	A prospective study of ultrasound-guided erector spinae plane block.
Region	Japan

Condition
Condition	Lung tumor
Classification by specialty	Chest surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Verifying the analgesic quality of ultrasound-guided continuous erector spinae plane block in video-assisted thoracic surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Numerical rating scale
Key secondary outcomes

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	Ultrasound-guided erector spinae plane block
Interventions/Control_2	Ultrasound-guided paravertebral block
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Provided written informed consent 2.American Society of Anesthesiologists physical status 1-3 3.Scheduled to undergo complete video-assisted thoracoscopic surgery for lung tumor.
Key exclusion criteria	Allergy to local anesthetics BMI>40 Age< 20 or >86 History of past ipsilateral thoracotomy Normally using opioid analgesics Treated mental or neurological disorders Allergy to acetaminophen and fentanyl. Difficulty in adequate verbal communication Thoracotomy with rib cutting or pleurectomy
Target sample size	88

Research contact person
Name of lead principal investigator	1st name Taro Middle name Last name Fujitani
Organization	Ehime Prefectural Central Hospital
Division name	Department of Anesthesiology and Critical Care
Zip code	790-0024
Address	83 Kasuga-machi Matsuyama-city, Ehime 790-0024
TEL	+81-89-947-1111
Email	suko1231@yahoo.co.jp

Public contact
Name of contact person	1st name Yasuko Middle name Last name Taketa
Organization	Ehime Prefectural Central Hospital
Division name	Department of Anesthesiology and Critical Care
Zip code	7900024
Address	83 Kasuga-machi Matsuyama-city, Ehime 790-0024
TEL	+81-89-947-1111
Homepage URL
Email	suko1231@yahoo.co.jp

Sponsor
Institute	Ehime Prefectural Central Hospital
Institute
Department

Funding Source
Organization	No funding
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	Institutional Review Board of Ehime Prefectural Hospital
Address	83 Kasuga-machi Matsuyama-city, Ehime 790-0024
Tel	+81-89-947-1111
Email	suko1231@yahoo.co.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	2018 Year 02 Month 01 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	88
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	Main results already published
Date of protocol fixation	2018 Year 01 Month 24 Day
Date of IRB	2018 Year 02 Month 16 Day
Anticipated trial start date	2018 Year 02 Month 18 Day
Last follow-up date	2019 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 01 Day
Last modified on	2019 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035002