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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021942
Receipt No. R000025307
Scientific Title Comparison of plasma concentrations of levobupivacaine with and without epinephrine for thoracic paravertebral block
Date of disclosure of the study information 2016/04/17
Last modified on 2017/10/18

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Basic information
Public title Comparison of plasma concentrations of levobupivacaine with and without epinephrine for thoracic paravertebral block
Acronym Comparison of plasma concentrations of levobupivacaine with and without epinephrine for thoracic paravertebral block
Scientific Title Comparison of plasma concentrations of levobupivacaine with and without epinephrine for thoracic paravertebral block
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Akinori Yamazaki
Organization Wakayama Medical University Hospital
Division name Department of Anesthesiology
Zip code
Address 811-1 Kimiidera Wakayamashi
TEL 073-447-2300
Email tesshii@wakayama-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Akinori Yamazaki
Organization Wakayama Medical University Hospital
Division name Department of Anesthesiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2014 Year 12 Month 15 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025307

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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