UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011267
Receipt number 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 18:09:59

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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 or person

Institute

Gifu University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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