UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030658 |
|---|---|
| Receipt number | R000035002 |
| Scientific Title | Comparison of ultrasound-guided paravertebral block and erector spinae plane block in postoperative analgesia after video-assisted thoracoscopic surgery: a prospective, randomized, non-inferiority trial. |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2019/10/16 22:10:36 |
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Basic information
Public title
Comparison of ultrasound-guided paravertebral block and erector spinae plane block in postoperative analgesia after video-assisted thoracoscopic surgery: a prospective, randomized, non-inferiority trial.
Acronym
A prospective study of ultrasound-guided erector spinae plane block.
Scientific Title
Comparison of ultrasound-guided paravertebral block and erector spinae plane block in postoperative analgesia after video-assisted thoracoscopic surgery: a prospective, randomized, non-inferiority trial.
Scientific Title:Acronym
A prospective study of ultrasound-guided erector spinae plane block.
Region
| Japan |
Condition
Condition
Lung tumor
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verifying the analgesic quality of ultrasound-guided continuous erector spinae plane block in video-assisted thoracic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical rating scale
Key secondary outcomes
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ultrasound-guided erector spinae plane block
Interventions/Control_2
Ultrasound-guided paravertebral block
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 tumor.
Key exclusion criteria
Allergy to local anesthetics
BMI>40
Age< 20 or >86
History of past ipsilateral thoracotomy
Normally using opioid analgesics
Treated mental or neurological disorders
Allergy to acetaminophen and fentanyl.
Difficulty in adequate verbal communication
Thoracotomy with rib cutting or pleurectomy
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Fujitani |
Organization
Ehime Prefectural Central Hospital
Division name
Department of Anesthesiology and Critical Care
Zip code
790-0024
Address
83 Kasuga-machi Matsuyama-city, Ehime 790-0024
TEL
+81-89-947-1111
suko1231@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Taketa |
Organization
Ehime Prefectural Central Hospital
Division name
Department of Anesthesiology and Critical Care
Zip code
7900024
Address
83 Kasuga-machi Matsuyama-city, Ehime 790-0024
TEL
+81-89-947-1111
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
Institutional Review Board of Ehime Prefectural Hospital
Address
83 Kasuga-machi Matsuyama-city, Ehime 790-0024
Tel
+81-89-947-1111
suko1231@yahoo.co.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
| 2018 | Year | 02 | 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
88
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
| 2018 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 01 | Day |
Last modified on
| 2019 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035002
