UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037136 |
|---|---|
| Receipt number | R000042297 |
| Scientific Title | The study of clinical usefulness of Erector Spinae Plane block in spinal surgery |
| Date of disclosure of the study information | 2019/06/25 |
| Last modified on | 2020/06/23 08:42:07 |
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Basic information
Public title
The study of clinical usefulness of Erector Spinae Plane block in spinal surgery
Acronym
The study of clinical usefulness of Erector Spinae Plane block in spinal surgery
Scientific Title
The study of clinical usefulness of Erector Spinae Plane block in spinal surgery
Scientific Title:Acronym
The study of clinical usefulness of Erector Spinae Plane block in spinal surgery
Region
| Japan |
Condition
Condition
Lumbar spine disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospectively verify the usefulness of the erector spinae plane block in pain control after spinal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperative and postoperative pain scale(NRS)
Key secondary outcomes
Intraoperative drug use, Postoperative analgesic use
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
In the block group, the spinae erector plane block is administered after induction of anesthesia. (Use 40 ml of 0.375% ropivacaine)
Interventions/Control_2
The control group performs anesthesia management as usual.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who undergo lumbar spine surgery
2) ASA-PS 1 or 2
3) Patients with surgery time within 3 hours and surgery site up to 3
4) Regarding the participation in this research, the person has obtained written consent by free will
Key exclusion criteria
1) After lumbar spine posterior fixation surgery
2) Emergency operation patients
3) Patients who can not obtain research consent
4) Preoperative NRS is 7 or more
5) Patients judged to be inappropriate by the investigator or in charge of the research
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Kurokawa |
Organization
Konan Kosei Hospital
Division name
Anesthesiology
Zip code
4838703
Address
Takaya Town Omatsubara 137, Konan City, Aichi Prefecture
TEL
0587513333
kurokawa@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Kurokawa |
Organization
Konan Kosei Hospital
Division name
Anesthesiology
Zip code
4838703
Address
Takaya Town Omatsubara 137, Konan City, Aichi Prefecture
TEL
0587513333
Homepage URL
kurokawa@aichi-med-u.ac.jp
Sponsor or person
Institute
Konan Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Konan Kosei Hospital
Address
Takaya Town Omatsubara 137, Konan City, Aichi Prefecture
Tel
0587513333
kurokawa@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 | 25 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | 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 | 06 | Month | 22 | Day |
Last modified on
| 2020 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042297
