UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005450 |
|---|---|
| Receipt number | R000006455 |
| Scientific Title | The efficacy of prioperative pregabalin administration for patients underwent decompression surgery for lumbar canal stenosis |
| Date of disclosure of the study information | 2011/04/18 |
| Last modified on | 2013/04/30 19:50:30 |
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Basic information
Public title
The efficacy of prioperative pregabalin administration for patients underwent decompression surgery for lumbar canal stenosis
Acronym
Perioperative pregabalin administration for patients with lumbar canal stenosis
Scientific Title
The efficacy of prioperative pregabalin administration for patients underwent decompression surgery for lumbar canal stenosis
Scientific Title:Acronym
Perioperative pregabalin administration for patients with lumbar canal stenosis
Region
| Japan |
Condition
Condition
Lumbar canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of perioperative administration of pregabalin in compare with that of NSAID.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analog scale, Zurich claudication questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
perioperative administration of pregabalin
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age; 20yo-80yo
2. Less than four level decompression
3. Preoperative VAS>40
4. Normal renal function
5. ASA<2
6. concet with the trail
Key exclusion criteria
1.Diabetes minitus
2.Psychological disorder
3.Liver dysfunction
4.Pregnancy
5.Alcholism
6.Asthma
7.Administration of opipid
8.Determination as contratindication by doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morio Matsumoto |
Organization
Keio Univ. School of Medcine
Division name
Dept. of Orthop. Surg.
Zip code
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Morio Matsumoto |
Organization
Keio Univ. School of Medicine
Division name
Dept. of Orthop. Surg.
Zip code
Address
35 Shinanomachi,Shinjyuku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Dept. of Orthop. Surg.Keio Univ. School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dept. of Orthop. Surg.Keio Univ. School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 04 | Month | 18 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 15 | Day |
Last modified on
| 2013 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006455
