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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010506
Receipt No. 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

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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
Email

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
Email to-be@f3.dion.ne.jp

Sponsor
Institute Keiyu orthopedic hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012288

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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