UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ropivacaine concentration on the distribution of neural blockade in continuous thoracic paravertebral block
Title of the study (Brief title)	Effect of ropivacaine concentration on the distribution of neural blockade in continuous thoracic paravertebral block
Region	Japan

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

Objectives
Narrative objectives1	In this prospective and randomized study, we evaluate the number of anesthetized dermatomes and the quality of postoperative analgesia produced by a continuous thoracic paravertebral infusion of 0.2% ropivacaine 6 mL/h compared with 0.5% ropivacaine 6mL/h after thoracic surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of anesthetized dermatomes 24 hours after surgery
Key secondary outcomes	1.Pain score (Numerical Rating Scale) assessed at 1 hour, 6, 24, and 48 hours after surgery 2.The consumption of additional analgesics 3.Patient satisfaction score 4.Sedation score (Richmond Agitation Sedation Scale) 5.Incidence of nausea and vomiting

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Postoperative continuous thoracic paravertebral block of ropivacaine 0.2% 6mL/h for 48 hours
Interventions/Control_2	Postoperative continuous thoracic paravertebral block of ropivacaine 0.5% 6mL/h for 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.Patients undergoing unilateral lung lobectomy or pulmonary segmentectomy at Niigata University Medical and Dental Hospital 2.American Society of Anesthesiologists Physical Status Classification I-III 3.Written informed consent is provided
Key exclusion criteria	1. Inability to communicate lucidly 2. Under 20 years old or over 80 years old 3. Bilateral thoracotomy 4. Patient with a past history of thoracotomy on the same side as the surgery 5. Allergy to local anesthetics 6. Contraindication to NSAIDs or fentanyl 7. ASA-PS > III 8. Hemodialysis patients 9. Body Mass Index > 30 kg/m^2 10. Body weight < 40 kg 11. Chronic opioid use 12. Neurological disability 13. Infections at the site of injection
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroshi Baba
Organization	Niigata University Graduate School of Medical and Dental Science
Division name	Department of Anesthesiology
Address	1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL	025-227-2328
Email	baba@med.niigata-u.ac.jp

Public contact
Name of contact person	Takayuki Yoshida
Organization	Niigata University Medical and Dental Hospital
Division name	Department of Anesthesiology
Address	1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL	025-227-2328
Homepage URL
Email	ytaka@med.niigata-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization	None
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	新潟大学医歯学総合病院

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 10 Day
Anticipated trial start date	2011 Year 10 Month 07 Day
Last follow-up date	2012 Year 10 Month 15 Day
Date of closure to data entry	2012 Year 10 Month 16 Day
Date trial data considered complete	2012 Year 10 Month 24 Day
Date analysis concluded	2012 Year 12 Month 31 Day

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

Management information
Registered date	2012 Year 08 Month 20 Day
Last modified on	2018 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010246