UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided thoracic paravertebral block in video-assisted thoracic surgery.
Title of the study (Brief title)	A randomized prospective study of two different infusion protocol of ultrasound-guided continuous thoracic paravertebral block.
Region	Japan

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

Objectives
Narrative objectives1	Verifying the difference of analgesic quality between two different drug infusion protocol for ultrasound-guided continuous thoracic paravertebral block in video-assisted thoracic surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of fentanyl that patients required bolus dose using IV-PCA
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Using programmed intermittent bolus infusion of 0.2% levobupivacaine for postoperative 48 hours.
Interventions/Control_2	Using continuous infusion of 0.2% levobupivacaine for postoperative 48 hours.
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 cancer.
Key exclusion criteria	allergy to local anesthetics BMI>30 age< 20 or >80 History of past ipsilateral thoracotomy Normally using opioid analgesics Treated mental or neurological disorders Allergy to acetaminophen, NSAIDs, and fentanyl. Difficulty in adequate verbal communication Thoracotomy with rib cutting or pleurectomy
Target sample size	70

Research contact person
Name of lead principal investigator	Taro Fujitani
Organization	Ehime Prefectural Central Hospital
Division name	Department of anesthesiology and clitical care
Address	83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL	089-947-1111
Email	suko1231@yahoo.co.jp

Public contact
Name of contact person	Yasuko Taketa
Organization	Ehime Prefectural Central Hospital
Division name	Department of anesthesiology and clitical care
Address	83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL	089-947-1111
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)

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	2016 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 28 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 28 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026927