UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010506 |
|---|---|
| Receipt number | R000012288 |
| Scientific Title | The effect of pregabalin for postoperative pain |
| Date of disclosure of the study information | 2013/04/17 |
| Last modified on | 2014/06/16 12:14:29 |
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Basic information
Public title
The effect of pregabalin for postoperative pain
Acronym
The effect of pregabalin for postoperative pain
Scientific Title
The effect of pregabalin for postoperative pain
Scientific Title:Acronym
The effect of pregabalin for postoperative pain
Region
| Japan |
Condition
Condition
The patient planned posterior lumbar interbody fusion surgery
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the analgesic effect of oral administration pregabalin before surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decrease the visual analog scale of postoperative pain
Key secondary outcomes
the amount of opioids for postoperative pain management
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
take orally diazepam 5mg before surgery
Interventions/Control_2
take orally pregabalin 75mg before surgery
Interventions/Control_3
take orally pregabalin 150mg before surgery
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
planned surgery
to communicate possible
accept for this clinical trial
American society of anesthesiologists physical status classification 1~2
Key exclusion criteria
aleready administrated patient with pregabalin or gabapentin
to communicate difficult
asthma
renal dysfunction(Cr>1.2mg/dl)
Body mass index>40
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nao Fujita |
Organization
Keiyu orthopedic hospital
Division name
department of anesthesiology
Zip code
Address
1741hanetsukucho Tatebayashi city in Gunma
TEL
0276-72-6000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Tobe |
Organization
Gunma university hospital
Division name
Intensive care unit
Zip code
Address
3-39-15 showacho Maebashi city in Gunma
TEL
027-220-7111
Homepage URL
to-be@f3.dion.ne.jp
Sponsor or person
Institute
Keiyu orthopedic hospital
Institute
Department
Personal name
Funding Source
Organization
Keiyu orthopedic hospital
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
慶友整形外科病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 17 | 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 | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 16 | Day |
Last modified on
| 2014 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012288
