UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019124 |
|---|---|
| Receipt number | R000021975 |
| Scientific Title | Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion. |
| Date of disclosure of the study information | 2015/09/30 |
| Last modified on | 2015/09/26 22:00:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion.
Acronym
Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion.
Scientific Title
Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion.
Scientific Title:Acronym
Efficacy of intravenous patient-controlled analgesia (IVPCA) in posterior spinal fusion.
Region
| Japan |
Condition
Condition
patients who undergo on posterior spinal fusion for degenerative spine disease and spinal trauma
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy of IV-PCA for the management of postoperative pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual analogue scale in patients one hour after surgery and postoperative day one
Key secondary outcomes
complications and usage of non-opioid analgesics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
usage of IVPCA after surgery for up to 100 hours
Interventions/Control_2
non-usage of IVPCA
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing elective posterior spinal fusion and general anesthesia
Key exclusion criteria
patients who have history of psychiatric disorder, cannot press the button of IVPCA
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Tomioka |
Organization
Saitama Red Cross Hospital
Division name
Anesthesia
Zip code
Address
Kamiochiai 8-3-33 Chuo-ku Saitama city Saitama Japan
TEL
048-852-1111
mmarico04@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiya Tomioka |
Organization
Saitama Red Cross Hospital
Division name
Anesthesia
Zip code
Address
Kamiochiai 8-3-33 Chuo-ku Saitama city Saitama Japan
TEL
048-852-1111
Homepage URL
mmarico04@yahoo.co.jp
Sponsor or person
Institute
Saitama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Red Cross Hospital
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 30 | 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
| 2015 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 15 | 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
| 2015 | Year | 09 | Month | 26 | Day |
Last modified on
| 2015 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021975
