UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033481 |
|---|---|
| Receipt number | R000038173 |
| Scientific Title | Efficacy of Erector Spinae Plane block for lumbar spine surgery :prospective study: |
| Date of disclosure of the study information | 2018/07/23 |
| Last modified on | 2018/07/23 16:44:10 |
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Basic information
Public title
Efficacy of Erector Spinae Plane block for lumbar spine surgery :prospective study:
Acronym
Efficacy of ESP block for lumbar spine surgery
Scientific Title
Efficacy of Erector Spinae Plane block for lumbar spine surgery :prospective study:
Scientific Title:Acronym
Efficacy of ESP block for lumbar spine surgery
Region
| Japan |
Condition
Condition
lumbar spine disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
prospective study of postoperative analgesic efficacy of erector spinae plane block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
amount of additional bolus fentanyl from intravenous patient-controlled-analgesia at 24 hour after operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
after general anesthesia induction, injecting 40 ml of 0.25% levobupivacaine as erector spinae plane block
Interventions/Control_2
after general anesthesia induction, injecting 40 ml of natural saline in area of erector spinae plane 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient scheduled lumbar spine surgery at Showa university hospital
patient who agree with the study
Key exclusion criteria
past history of lumbar spine surgery
scheduled emergency lumbar spine surgery
allergy with local anesthesia
hepatic or renal abnormality in blood test
regarded as unfit by examination doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Ueshima |
Organization
Showa university
Division name
department of anesthesiology
Zip code
Address
1-5-8, Hatanodai Shinagawa-ku Tokyo
TEL
03-3784-8000
ueshimhi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Inagaki |
Organization
Showa university
Division name
department of anesthesiology
Zip code
Address
1-5-8, Hatanodai Shinagawa-ku Tokyo
TEL
03-3784-8000
Homepage URL
mymhtt0120@gmail.com
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
Funding Source
Organization
Showa 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
Address
Tel
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
昭和大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 23 | 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
| 2018 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 23 | 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
| 2018 | Year | 07 | Month | 23 | Day |
Last modified on
| 2018 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038173
