UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042077 |
|---|---|
| Receipt number | R000047597 |
| Scientific Title | A prospective study of the efficacy of postoperative sedation with intraoperative subarachnoid opioids |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/10/11 16:28:59 |
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Basic information
Public title
The therapeutic effect of an intrathecal opioid after lumbar interbody fusion surgery
Acronym
The therapeutic effect of an intrathecal opioid after lumbar interbody fusion surgery
Scientific Title
A prospective study of the efficacy of postoperative sedation with intraoperative subarachnoid opioids
Scientific Title:Acronym
A prospective study of the efficacy of postoperative sedation with intraoperative subarachnoid opioids
Region
| Japan |
Condition
Condition
Degenerative lumber disease
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Therapeutic Effect of Intrathecal Morphine After Posterior Lumbar Surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain and side-effect will be researced 4,8,and 24hours post-surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intrathecal Morphine
Interventions/Control_2
not injected
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 who will be undergone spinal fusion surgery
Key exclusion criteria
infection
hematoma
trauma
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kobayashi |
Organization
Akita Kousei Medical Center
Division name
Deparatment of Orthopedic Surgery
Zip code
0110948
Address
1-1-1, Iijima Nishifukuro, Akita-city, Akita-prefecture, Japan
TEL
018-880-3000
takakoba825@hotmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kobayashi |
Organization
Akita Kousei Medical Center
Division name
Department of Orthopedic Surgery
Zip code
011-0948
Address
1-1-1, Iijima Nishifukuro, Akita-city, Akita-prefecture, Japan
TEL
018-880-3000
Homepage URL
takakoba825@hotmail.com
Sponsor or person
Institute
Akita Kousei Medical Center
Department of Orthopedic Surgery
Institute
Department
Personal name
Funding Source
Organization
Akita Kousei Medical Center
Department of Orthopedic Surgery
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
Akita Kousei Medical Center
Address
1-1-1, Iijima Nishifukuro, Akita-city, Akita-prefecture, Japan
Tel
0188803000
takakoba825@hotmail.com
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
秋田厚生医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | 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
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | 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
| 2020 | Year | 10 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047597
