UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021942 |
|---|---|
| Receipt number | 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 16:21:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tesshii@wakayama-med.ac.jp
Public contact
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
tesshii@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025307
