UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of automated intermittent thoracic paravertebral bolus technique for analgesia after thoracotomies: prospective, randomized, controlled, double-blind study
Title of the study (Brief title)	The efficacy of automated intermittent thoracic paravertebral bolus technique for analgesia after thoracotomies: prospective, randomized, controlled, double-blind study
Region	Japan

Condition
Condition	Adult patients scheduled for elective unilateral thoracotomy (lung lobectomy or pulmonary segmentectomy) under combination of general anesthesia and thoracic paravertebral block
Classification by specialty	Chest surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to determine if an automated intermittent thoracic paravertebral bolus decreases post-thoracotomy pain more effectively when compared with a continuous thoracic paravertebral infusion.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Anesthetized dermatomes by thoracic paravertebral block 24 h after surgery
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	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Postoperative continuous thoracic paravertebral infusion of 0.2% levobupivacaine at 5 ml/h for 48 h
Interventions/Control_2	Postoperative automated intermittent thoracic paravertebral bolus of 0.2% levobupivacaine 10 ml every 2 hours for 48 h
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.Patients undergoing elective unilateral lung lobectomy or pulmonary segmentectomy at Nagasaki University Hospital 2.American Society of Anesthesiologists Physical Status Classification I-III 3.Patients signed the informed consent form
Key exclusion criteria	1.Age < 20 or > 80 years 2.Prior thoracotomy on ipsilateral side 3.Body mass index > 30 kg/m2 4.Body weight < 40 kg 5.Allergy to local anesthetics 6.Contraindication to non-steroidal anti-inflammatory drugs, fentanyl, iodinated contrast medium 7.Hepatic or renal failure 8.Chronic opioid use 9.Pre-existing neurological deficit 10.Infection at the site of injection 11.Bronchial asthma 12.Inability to communicate lucidly
Target sample size	32

Research contact person
Name of lead principal investigator	Hiroaki Murata
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Anesthesiology
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL	095-819-7370
Email	h-murata@nagasaki-u.ac.jp

Public contact
Name of contact person	Hiroaki Murata
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Anesthesiology
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL	095-819-7370
Homepage URL
Email	h-murata@nagasaki-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Nagasaki University School of Medicine
Institute
Department

Funding Source
Organization	Smiths Medical Japan Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	長崎大学病院（長崎県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 24 Day
Anticipated trial start date	2016 Year 05 Month 31 Day
Last follow-up date	2017 Year 01 Month 14 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 10 Month 12 Day
Date analysis concluded	2017 Year 12 Month 15 Day

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

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2018 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023302