UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049828 |
|---|---|
| Receipt number | R000056753 |
| Scientific Title | Investigation of the effectiveness of fluoroscopic erector spine plane block |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2025/01/06 20:14:52 |
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Basic information
Public title
Investigation of the effectiveness of fluoroscopic erector spine plane block
Acronym
Investigation of the effectiveness of fluoroscopic erector spine plane block
Scientific Title
Investigation of the effectiveness of fluoroscopic erector spine plane block
Scientific Title:Acronym
Investigation of the effectiveness of fluoroscopic erector spine plane block
Region
| Japan |
Condition
Condition
Posterior lumbar fusion of one or two vertebrae
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the efficacy of fluoroscopic erector spine plane block by comparing three groups: fluoroscopic erector spine plane block group, ultrasound erector spine plane block group, and control group (no block).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative low back pain VAS (0hr, 1hr, 2hr, 6hr, 12hr, 24hr, first walk after drain removal)
Key secondary outcomes
Age
Sex
Body weight
Duration of blocking procedure
iv-PCA consumption in the first 24 hours after surgery
Number of times rescue drug (1000 mg IV acetaminophen) was used
Time from postoperative to first rescue drug delivery
Satisfaction (on a scale of 1-5)
Number of cases of high-level mistakes in the ultrasound group
Dose area product
Duration of radiation exposure
Complications of ESPB (paraplegia, local anesthesia, needle site infection)
Postoperative hematoma
Dural injury
Postoperative infection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
fluoroscopic erector spine plane block group
Interventions/Control_2
ultrasound erector spine plane block group
Interventions/Control_3
control group (no block)
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
Patients body weight more than 45kg and less than 100kg
American Society of Anesthesiologists grade I, II, or III
Patients who will undergo 1- or 2-vertebral open lumbar posterior fusion
Key exclusion criteria
Previous spinal surgery
Renal dysfunction (eGFR<60mL/min/1.73m2)
Hepatic dysfunction (AST>30, ALT>30)
drug (loxoprofen Na, acetaminophen, ropivacaine, fentanyl) allergy
Complicated pyogenic spondylitis
Complicated spinal fracture
Complicated bladder and rectal disorders
Complicated preoperative paresthesia of the lower extremities with inability to walk
Complications of malignant tumor
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Shusuke |
| Middle name | |
| Last name | Hagihara |
Organization
Faculty of Medicine, Fukuoka University
Division name
Department of Orthopedics Surgery
Zip code
810-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 810-0180, Japan
TEL
092-801-1011
s.hagihara1410@gmail.com
Public contact
Name of contact person
| 1st name | Shusuke |
| Middle name | |
| Last name | Hagihara |
Organization
Faculty of Medicine, Fukuoka University
Division name
Department of Orthopedics Surgery
Zip code
810-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 810-0180, Japan
TEL
092-801-1011
Homepage URL
s.hagihara1410@gmail.com
Sponsor or person
Institute
Fukuoka University
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
Department of Life Medical Ethics, Fukuoka University
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 810-0180, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2022 | Year | 12 | Month | 26 | 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
45
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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056753
