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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011267
Receipt No. R000013201
Scientific Title Assessment of the treatment effect of tramadol in patients with post-thoracotomy pain
Date of disclosure of the study information 2013/08/01
Last modified on 2013/07/24

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Basic information
Public title Assessment of the treatment effect of tramadol in patients with post-thoracotomy pain
Acronym Assessment of the treatment effect of tramadol in patients with post-thoracotomy pain
Scientific Title Assessment of the treatment effect of tramadol in patients with post-thoracotomy pain
Scientific Title:Acronym Assessment of the treatment effect of tramadol in patients with post-thoracotomy pain
Region
Japan

Condition
Condition patients with post-thoracotomy pain
Classification by specialty
Chest surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of tramadol in patients who complain of post-thoracotomy pain after epidural anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes VAS(Visual Analogue Scale) at 2week (at rest, at coughing)
Key secondary outcomes 1)VAS at day 0 to 7, 4week and 3month (pain at rest or at coughing)
2)VAS before breakfast, lunch and dinner at day 2 and 3(pain at rest or at coughing)
3)SF-MPQ
4)EQ-MPQ
5)Sleep disorder score
6)incidence of adverse reaactions
7)number of rescure medication use
8)scleening tool of neuropathic pain at month 3

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Contorol group(Standerd treatment group)
The following treatments for 2 weeks
-Codeine phsphate power 25mg, TID
-Acetaminophen 400mg, TID
Interventions/Control_2 Study treatment group(Tramadol group)
-Tramadol hydrochloride 25mg, TID
-Acetaminophen 400mg, TID
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Lung cancer patients who recerived thoracotomy
2.Patients who complain of
3.Patients who are 20 years old or older
4.Patients who agreed to participate in the study and signed informed consent form
Key exclusion criteria 1.Patients with severe renal impairment
2.Patients with pneumothorax or who received mediastinotomy
3.Patients with interstitial pneumonia
4.Patients with history of a previous ipsilateral thoracotomy
5.Patients who used opioids,gabapentine, and/or pregabalin before surgery
6.Other patients considered to be ineligible to participate in the study by the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Iida
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 1-1 Yanagido, Gifu City, Gifu, 501-1194
TEL 058-230-6404
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noritaka Yoshimura
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 1-1 Yanagido, Gifu City, Gifu, 501-1194
TEL 058-230-6404
Homepage URL
Email

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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 岐阜大学医学部附属病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 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
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 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
2013 Year 07 Month 24 Day
Last modified on
2013 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013201

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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