UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of catheter tip location on the spread of sensory block produced by continuous thoracic paravertebral block: a prospective, randomized, double-blind study
Title of the study (Brief title)	Effect of catheter tip location on the spread of sensory block produced by continuous thoracic paravertebral block
Region	Japan

Condition
Condition	Patients scheduled for a unilateral video-assisted thoracic surgery
Classification by specialty	Chest surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will evaluate the influence of paravertebral catheter tip location on the spread of sensory block that is produced by a continuous thoracic paravertebral block.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of anesthetized dermatomes 24 h after surgery
Key secondary outcomes	Number of anesthetized dermatomes 2 h after surgery Spread of contrast dye injected into the paravertebral space Pain scale Sedation level Incidence of postoperative nausea and vomiting Incidence of local anesthetic systemic toxicity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
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	Maneuver
Interventions/Control_1	Catheters will be inserted into the thoracic paravertebral space, where is ventral to the endothoracic fascia, under ultrasound guidance.
Interventions/Control_2	Catheters will be inserted into the thoracic paravertebral space, where is dorsal to the endothoracic fascia, under ultrasound guidance.
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 video-assisted thoracic surgery at Niigata University Medical and Dental Hospital 2. Written informed consent is provided
Key exclusion criteria	1. American Society of Anesthesiologists Physical Status over 4 2. Inability to communicate lucidly 3. Under 20 or over 80 years old 4. Body Mass Index >30 kg/m^2 5. Body weight <40 kg 6. Contraindication or allergy to drugs used in this study 7. Renal or hepatic failure 8. Pre-existing sensory disturbance of the trunk 9. Patients requiring a posterolateral thoracotomy extending within 2 cm from the catheter insertion site 10. Previous ipsilateral thoracotomy 11. Infection at the catheter insertion site 12. Intrathoracic placement of the catheter 13. Patients who are regarded ineligible by researchers with any other reasons
Target sample size	50

Research contact person
Name of lead principal investigator	Takayuki Yoshida
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Anesthesiology
Address	1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL	025-227-2328
Email	ytaka@mac.com

Public contact
Name of contact person	Takayuki Yoshida
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Anesthesiology
Address	1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL	025-227-2328
Homepage URL
Email	ytaka@mac.com

Sponsor
Institute	Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization	Division of Anesthesiology, Niigata University Graduate School of Medical and Dental Sciences
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（新潟県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 15 Day
Anticipated trial start date	2015 Year 08 Month 07 Day
Last follow-up date	2016 Year 04 Month 01 Day
Date of closure to data entry	2016 Year 04 Month 02 Day
Date trial data considered complete	2016 Year 04 Month 02 Day
Date analysis concluded	2016 Year 04 Month 10 Day

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

Management information
Registered date	2015 Year 08 Month 07 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=R000021255