UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037772 |
|---|---|
| Receipt number | R000042943 |
| Scientific Title | Analgesic effect of the posterior spinal nerve medial branch block in posterior lumbar intervertebral fusion: A randomized controlledtrial |
| Date of disclosure of the study information | 2019/08/24 |
| Last modified on | 2022/10/24 17:51:22 |
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Basic information
Public title
Analgesic effect of the posterior spinal nerve medial branch block in posterior lumbar intervertebral fusion: A randomized controlled trial
Acronym
Analgesic effect of posterior spinal nerve medial branch block in posterior lumbar intervertebral fusion
Scientific Title
Analgesic effect of the posterior spinal nerve medial branch block in posterior lumbar intervertebral fusion: A randomized controlledtrial
Scientific Title:Acronym
Analgesic effect of posterior spinal nerve medial branch block in posterior lumbar intervertebral fusion
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 posterior spinal nerve medial branch block in posterior intervertebral fusion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain scale(NRS)
Key secondary outcomes
The duration of the first additional analgesics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
the posterior spinal nerve medial branch block
Interventions/Control_2
Without nerve 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing posterior intervertebral fusion
Key exclusion criteria
1)Patients who can not obtain research consent
2)Patients with previous spine surgery
3)Patients with allergies to local anesthetics
4)Liver failure
5)Renal failure
6)Heart failure
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshimatsu |
Organization
Ogikubo Hospital
Division name
Anesthesiology
Zip code
1670035
Address
3-1-24 Imagawa.Suginami-ku,Tokyo
TEL
0333991101
user68545141@aol.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshimatsu |
Organization
Ogikubo Hospital
Division name
Anesthesiology
Zip code
1670035
Address
3-1-24 Imagawa.Suginami-ku,Tokyo
TEL
0333991101
Homepage URL
user68545141@aol.com
Sponsor or person
Institute
Ogikubo Hospital
Institute
Department
Personal name
Funding Source
Organization
Ogikubo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ogikubo Hospital
Address
3-1-24 Imagawa.Suginami-ku,Tokyo
Tel
0333991101
chiken@ogikubo-hospital.or.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 | 08 | Month | 24 | 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
20
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
| 2019 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | 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 | 08 | Month | 22 | Day |
Last modified on
| 2022 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042943
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
