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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007590
Receipt No. R000008354
Scientific Title Effect of pregabarin for intercostal neuralgia associated with Stoney incision after thoracic aortic replacement
Date of disclosure of the study information 2012/04/01
Last modified on 2020/09/08

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Basic information
Public title Effect of pregabarin for intercostal neuralgia associated with Stoney incision after thoracic aortic replacement
Acronym PRETH study
Scientific Title Effect of pregabarin for intercostal neuralgia associated with Stoney incision after thoracic aortic replacement
Scientific Title:Acronym PRETH study
Region
Japan

Condition
Condition thoracic aortic aneurysm requiring Stoney incision
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of pregabarin for intercostal neuralgia associated with Stoney incision
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in pain score (Visual Analog Scale; VAS) between pre- and post-medcation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pregabarin 150mg/day for 30 days
Interventions/Control_2 placebo for 30 days
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
100 years-old >
Gender Male and Female
Key inclusion criteria patients undergoing thoracic aortic repair through a Stoney incision
Key exclusion criteria -pregnant woman
-less than 40 mm of maximal level of visual analogue scale (VAS) for 4 days following extubation (cf. )(0 mm, no pain; 100 mm, worst pain imaginable)
-diabateic patietns with neuropathy
-patients with neuropathy from organic brain syndrome
-allergy to pregabalin
-patients with severe liver dysfuntion (CTCAE grade 3 or 4)
-patients who have taken analgesic regularly
-patient who does not consent to this study
-patient who is deemed by a physician to be unsuitable for study entry
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoshikatsu
Middle name
Last name Saiki
Organization Tohoku University Graduate School of Medicine
Division name Division of Cardiovascular Surgery
Zip code 980-8574
Address 1-1 Seiryocho, Aoba-ku, Sendai 980-8574, Japan
TEL 022-717-7222
Email yoshisaiki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Matsuo
Organization Tohoku University Graduate School of Medicine
Division name Division of Cardiovascular Surgery
Zip code 980-8574
Address 1-1 Seiryocho, Aoba-ku, Sendai 980-8574, Japan
TEL 022-717-7222
Homepage URL
Email a0mb1082-thk@umin.ac.jp

Sponsor
Institute Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding
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 IRB of Tohoku University Graduate School of Medicine
Address 1-1 Seiryocho, Aoba-ku, Sendai 980-8574, Japan
Tel 022-717-8007
Email med-kenkyo@bureau.tohoku.ac.jp

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 東北大学大学院医学系研究科心臓血管外科

Other administrative information
Date of disclosure of the study information
2012 Year 04 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 Open public recruiting
Date of protocol fixation
2012 Year 03 Month 31 Day
Date of IRB
2012 Year 04 Month 01 Day
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2021 Year 12 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
2012 Year 03 Month 28 Day
Last modified on
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008354

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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