UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010044 |
|---|---|
| Receipt number | R000011763 |
| Scientific Title | Effect of ultrasound-guided thoracic paravertebral block in video-assisted thoracoscopic surgery for lung tumor |
| Date of disclosure of the study information | 2013/02/14 |
| Last modified on | 2017/02/21 21:03:36 |
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Basic information
Public title
Effect of ultrasound-guided thoracic paravertebral block in video-assisted thoracoscopic surgery for lung tumor
Acronym
Effect of ultrasound-guided thoracic paravertebral block in video-assisted thoracoscopic surgery for lung tumor
Scientific Title
Effect of ultrasound-guided thoracic paravertebral block in video-assisted thoracoscopic surgery for lung tumor
Scientific Title:Acronym
Effect of ultrasound-guided thoracic paravertebral block in video-assisted thoracoscopic surgery for lung tumor
Region
| Japan |
Condition
Condition
Patients scheduled for video-assisted thoracic surgery undergoing general anesthesia
Classification by specialty
| Surgery in general | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the evaluate differences in blood concentration and postoperative analgesia between ropivacaine and levobupivacaine and check to the influence of cardiovascular system and analgesia after ultrasound-guided thoracic paravertebral block.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The blood concentrations of the regional anesthetic agent was measured by using the liquid chromatography coupled with tandem mass spectrometry after
Ultrasound-guided thoracic paravertebral block.
Key secondary outcomes
Blood pressure and heart rate were also measured both before and after administration of the study drugs.
Ropivacaine or levobupivacaine as administered via the catheter at 6 mL/h, and fentanyl was administered via intravenous patient-controlled analgesia (CADD Legacy, Smiths Medical). The consumption of fentanyl over 24 h was measured.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Ultrasound-guided thoracic paravertebral block with ropivacaine 0.375%
Interventions/Control_2
Ultrasound-guided thoracic paravertebral block with levobupivacaine 0.375%
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of ASA physical status 1 or 2 scheduled for video-assisted thoracic surgery.
Key exclusion criteria
1.Patients of ASA physical status 3 or 4.
2.Patients undergoing artifical dialysis.
3.Patients with hepatic failure.
4.Patients with infection
5.Patients with heart failur (NYHA 3 or 4)
6.patients with arrhythmia.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Iida |
Organization
Asahikawa Medical University
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
Midorigaoka-higashi 2-1-1-1,Asahikawa,Hokkaido,Japan
TEL
0166-68-2583
takka1845@fg7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Iida |
Organization
Asahikawa Medical University
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
Midorigaoka-higashi 2-1-1-1,Asahikawa,Hokkaido,Japan
TEL
0166-68-2583
Homepage URL
takka1845@fg7.so-net.ne.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care Medicine,Asahikawa 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
| 2013 | Year | 02 | Month | 14 | 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
The blood concentration of levobupivacaine decreases earlier than that of ropivacaine after administration(after 90min); however, no difference was observed regarding the influence of either drug on hemodynamics.
Moreover, our results suggest that levobupivacaine reduces postoperative fentanyl requirements to a greater extent than ropivacaine. The total blood concentration of both regional anesthetic agent was less than 2.2ug/mL.
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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 14 | Day |
Last modified on
| 2017 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011763
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
