UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038191 |
|---|---|
| Receipt number | R000043505 |
| Scientific Title | Efficacy of Erector Spinae Plane Block Compared with Epidural Analgesia in Patients Undergoing Video-assisted Thoracoscopic Surgery |
| Date of disclosure of the study information | 2019/10/05 |
| Last modified on | 2020/04/11 14:26:26 |
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Basic information
Public title
Efficacy of Erector Spinae Plane Block Compared with Epidural Analgesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Acronym
Efficacy of Erector Spinae Plane Block Compared with Epidural Analgesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Scientific Title
Efficacy of Erector Spinae Plane Block Compared with Epidural Analgesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Scientific Title:Acronym
Efficacy of Erector Spinae Plane Block Compared with Epidural Analgesia in Patients Undergoing Video-assisted Thoracoscopic Surgery
Region
| Japan |
Condition
Condition
lung cancer, pneumothorax
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The comparison of the clinical effect between the erector spinae plane block and epidural block for the postoperative analgesia in the patients of video-assisted thracoscopic lung resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain score (Numerical Rating Scale)
Key secondary outcomes
some of the complication
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
The administration of the erector spinae plane block for the postoperative analgesia in the patients scheduled for video-assisted thoracic surgery
Interventions/Control_2
The administration of the epidural block for the postoperative analgesia in the patients undergoing video-assisted thoracic surgery
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA Physical status i-iii patients scheduled for
a video-assisted thoracic surgery
Key exclusion criteria
Patients who do not consented with this study
Patients undergoing anticoagulation therapy
Patients of unplanned conversion to thoracotomy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Ogawa |
Organization
Suwa Red Cross Hospital
Division name
Department of Anesthesiology
Zip code
392-8510
Address
5-11-50 Kogandori, Suwa, Nagano
TEL
0266-52-6111
marie.o@suwa.jrc.or.jp
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Ogawa |
Organization
Suwa Red Cross Hospital
Division name
Department of Anesthesiology
Zip code
392-8510
Address
5-11-50 Kogandori, Suwa, Nagano
TEL
0266-52-6111
Homepage URL
marie.o@suwa.jrc.or.jp
Sponsor or person
Institute
Department of Anesthesiology, Suwa Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Suwa Red Cross Hospital
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
Suwa Red Cross Hospital
Address
5-11-50 Kogandori, Suwa, Nagano
Tel
0266-52-6111
jinji@suwa.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
| 2019 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 03 | Day |
Last modified on
| 2020 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043505
