UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023378 |
|---|---|
| Receipt number | R000026927 |
| Scientific Title | A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided thoracic paravertebral block in video-assisted thoracic surgery. |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/01/29 11:45:12 |
* 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
A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided thoracic paravertebral block in video-assisted thoracic surgery.
Acronym
A randomized prospective study of two different infusion protocol of ultrasound-guided continuous thoracic paravertebral block.
Scientific Title
A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided thoracic paravertebral block in video-assisted thoracic surgery.
Scientific Title:Acronym
A randomized prospective study of two different infusion protocol of ultrasound-guided continuous thoracic paravertebral block.
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verifying the difference of analgesic quality between two different drug infusion protocol for ultrasound-guided continuous thoracic paravertebral block in video-assisted thoracic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of fentanyl that patients required bolus dose using IV-PCA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Using programmed intermittent bolus infusion of 0.2% levobupivacaine for postoperative 48 hours.
Interventions/Control_2
Using continuous infusion of 0.2% levobupivacaine for postoperative 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.Provided written informed consent
2.American Society of Anesthesiologists physical status 1-3
3.Scheduled to undergo complete video-assisted thoracoscopic surgery for lung cancer.
Key exclusion criteria
allergy to local anesthetics
BMI>30
age< 20 or >80
History of past ipsilateral thoracotomy
Normally using opioid analgesics
Treated mental or neurological disorders
Allergy to acetaminophen, NSAIDs, and fentanyl.
Difficulty in adequate verbal communication
Thoracotomy with rib cutting or pleurectomy
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Fujitani |
Organization
Ehime Prefectural Central Hospital
Division name
Department of anesthesiology and clitical care
Zip code
Address
83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL
089-947-1111
suko1231@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko Taketa |
Organization
Ehime Prefectural Central Hospital
Division name
Department of anesthesiology and clitical care
Zip code
Address
83 Kasuga-cho Matsuyama-city, Ehime 790-0024
TEL
089-947-1111
Homepage URL
suko1231@yahoo.co.jp
Sponsor or person
Institute
Ehime Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding
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 | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026927
