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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010044
Receipt No. 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

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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
Email 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
Email takka1845@fg7.so-net.ne.jp

Sponsor
Institute Department of Anesthesiology and Critical Care Medicine,Asahikawa 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011763

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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