UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036822 |
|---|---|
| Receipt number | R000041916 |
| Scientific Title | Efficacy of erector spinae plane block on postoperative analgesia after thoracoscopic surgery |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2019/05/22 17:30:27 |
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Basic information
Public title
Efficacy of erector spinae plane block on postoperative analgesia after thoracoscopic surgery
Acronym
Efficacy of erector spinae plane block on postoperative analgesia after thoracoscopic surgery
Scientific Title
Efficacy of erector spinae plane block on postoperative analgesia after thoracoscopic surgery
Scientific Title:Acronym
Efficacy of erector spinae plane block on postoperative analgesia after thoracoscopic surgery
Region
| Japan |
Condition
Condition
Patients undergoing thoracoscopic surgery
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of ESP block on analgesia after thoracoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of fentanyl required within postoperative 24 hours
Key secondary outcomes
VAS pain score at rest and with movement, itchiness, nausea/vomitting, sleepiness, and area of hypaesthesia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ESP block
Postoperative 2 days
Programmed intermittent bolus of local anesthetic
Interventions/Control_2
Local anesthtic infiltration
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
Contraindication to epidural catheterization
Key exclusion criteria
Patients with severe condition
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hashimoto |
Organization
Aichi Medical University
Division name
Department of Anesthesiology
Zip code
4801195
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561623311
atsushih@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hashimoto |
Organization
Aichi Medical University
Division name
Department of Anesthesiology
Zip code
4801195
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561623311
Homepage URL
atsushih@aichi-med-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Self 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
Aichi Medical University
Address
1-1, Yazakokarimata, Nagakute, Aichi
Tel
0561623311
atsushih@aichi-med-u.ac.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 | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | 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 | 05 | Month | 22 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041916
