UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023474 |
|---|---|
| Receipt number | R000020576 |
| Scientific Title | A prospective, randomized comparison of paravertebral vs intercostal nerve blockade for video-assied thoracoscopic surgery |
| Date of disclosure of the study information | 2016/08/04 |
| Last modified on | 2020/05/10 23:06:24 |
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Basic information
Public title
A prospective, randomized comparison of paravertebral vs intercostal nerve blockade for video-assied thoracoscopic surgery
Acronym
Comparison of paravertebral vs intercostal nerve blockade for VATS thoracic surgery
Scientific Title
A prospective, randomized comparison of paravertebral vs intercostal nerve blockade for video-assied thoracoscopic surgery
Scientific Title:Acronym
Comparison of paravertebral vs intercostal nerve blockade for VATS thoracic surgery
Region
| Japan |
Condition
Condition
Lung tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of PVB and intercostal nerve block after VATS lobectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain scale after operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Paravertebral block catheter was inserted by the srugeon under direct vision before chest closure
Interventions/Control_2
Intercostal block catheter was inserted by the srugeon under direct vision before chest closure
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA PS one, two and three
Aged from twenty to eighty five
Obtaning informed patient consent
VATS lobectomy including left segmentectomy
Key exclusion criteria
Past history of same side thoracotomy
Risk of pleural adhesion
Past history of radiotherapy
Allergy to local anaesthetics or opioid
A woman who is pregnant, or may be pregnant
Sepsis
infection of puncuture skin
Having mental troubles
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Mori |
Organization
Japanese Red Cross Nagoya Daiichi Hospital
Division name
Department of Thoracic Surgery
Zip code
453-0046
Address
Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan
TEL
0524815111
smori@nagoya-1st.jrc.or.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Kadomatsu |
Organization
Japanese Red Cross Nagoya Daiichi Hospital
Division name
Department of Thoracic Surgery
Zip code
453-0046
Address
Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan
TEL
0524815111
Homepage URL
yuka.kadomatsu@gmail.com
Sponsor or person
Institute
Japanese Red Cross Nagoya Daiishi Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding source
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
Japanese Red Cross Nagoya Daiichi Hospital
Address
Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan
Tel
052-485-1121
yoko@nagoya-1st.jrc.or.jp
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 | 04 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s11748-018-0936-8
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s11748-018-0936-8
Number of participants that the trial has enrolled
50
Results
Our results could not clearly establish noninferiority of ICB to PVB. Improvements in ICB may be necessary for it to be used as an alternative method to PVB.
Results date posted
| 2020 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
PVG group: 26 cases, ICT group: 24 cases
There were no significant differences in the characteristics between the two groups except for laterality.
Participant flow
Preoperative random allocation to PVB or ICT group.
Adverse events
None
Outcome measures
Postoperative pain
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2020 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020576
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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