UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035698 |
|---|---|
| Receipt number | R000040660 |
| Scientific Title | Analgesic effect of erector spinae plane block in spine surgery: A randomized controlled trial |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2021/01/29 09:43:10 |
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Basic information
Public title
Analgesic effect of erector spinae plane block in spine surgery: A randomized controlled trial
Acronym
Analgesic effect of erector spinae plane block in spine surgery
Scientific Title
Analgesic effect of erector spinae plane block in spine surgery: A randomized controlled trial
Scientific Title:Acronym
Analgesic effect of erector spinae plane block in spine surgery
Region
| Japan |
Condition
Condition
spine disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the analgesic effect of ultrasound-guided erector spinae plane (ESP) blockin spine surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total postoperative fentanyl consumption in the first 24 h between the groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Bilateral ESP block with 15 ml 0.5% levobupivacaine at the L1-5 vertebral level is performed before general anesthesia in prone position.(Under 50 kg: 0.5% levobupivacaine 3 mg/kg)
Interventions/Control_2
General anesthesia without ESP 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) Patients with elective lumbar spine surgery
2) ASA PS (American Society of Anesthesiologists physical status physical status):1-3
3) Obtaining consent form from patients
Key exclusion criteria
1) Emergency surgery
2) Patients with previous spine surgery
3) Spinal fusion surgery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noritaka |
| Middle name | |
| Last name | Imamachi |
Organization
Shimane University
Division name
Department of Anesthesiology
Zip code
6938501
Address
89-1 Enyacho Izumo Shimane
TEL
0853202295
imamachi@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Yawata |
Organization
Shimane University
Division name
Anesthesiology
Zip code
6938501
Address
89-1 Enyacho Izumo Shimane
TEL
0853202295
Homepage URL
shunsuke.tottorin@gmail.com
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University
Address
89-1 Enyacho Izumo Shimane
Tel
0853202295
imamachi@med.shimane-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 | 02 | 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 | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040660
| 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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| Registered date | File name |
