UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of plasma concentrations of levobupivacaine with and without epinephrine for thoracic paravertebral block
Title of the study (Brief title)	Comparison of plasma concentrations of levobupivacaine with and without epinephrine for thoracic paravertebral block
Region	Japan

Condition
Condition	Patients who were scheduled to undergo elective unilateral pulmonary lobectomy or segmentectomy under general anesthesia combined with thoracic paravertebral block for a lung cancer.
Classification by specialty	Chest surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We studied the pharmacokinetics for levobupivacaine after thoracic paravertebral block and the effect of addition of epinephrine on plasma concentrations of levobupivacaine.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The plasma concentration of levobupivacaine was measured at 1, 2.5, 5, 7.5, 10, 12.5, 15, 20, 30, 45, 60, 90, 120 and 150 minutes after paravertebral block. The peak plasma concentration and the time to peak plasma concentration for levobupivacaine were recorded directly from the measured values. The area under the plasma concentration time curve was calculated using the trapezoidal rule.
Key secondary outcomes	Pain:Numerical Rating Scale at rest and at cough after 6,12, 24, 48, and 72 hours postoperation.

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	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patinets will receive ultrasound-guided thoracic paravertebral block using 0.25%, 1 mg/kg of levobupivacaine.
Interventions/Control_2	Patinets will receive ultrasound-guided thoracic paravertebral block using 0.25%, 1 mg/kg of levobupivacaine with 5 microg/ml epinephrine.
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	79 years-old >=
Gender	Male
Key inclusion criteria	1)Patients who are scheduled for unilateral pulmonary lobectomy or segmentectomy under general anesthesia combined with thoracic paravertebral block in Wakayama medical university hospital. 2)American Society of Anethesiologists physical status in 1, 2 or 3. 3)Patients who can give written informed consent.
Key exclusion criteria	1)Patients who have contraindication of thoracic paravertebral block. 2)Patients who have allergy to the drugs which will going to use in this trial. 3)Patients who are regarded ineligible by doctors with ather reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	Akinori Yamazaki
Organization	Wakayama Medical University Hospital
Division name	Department of Anesthesiology
Address	811-1 Kimiidera Wakayamashi
TEL	073-447-2300
Email	tesshii@wakayama-med.ac.jp

Public contact
Name of contact person	Akinori Yamazaki
Organization	Wakayama Medical University Hospital
Division name	Department of Anesthesiology
Address	811-1 Kimiidera Wakayamashi
TEL	073-447-2300
Homepage URL
Email	tesshii@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 17 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 12 Month 15 Day
Anticipated trial start date	2014 Year 12 Month 15 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 17 Day
Last modified on	2017 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025307