UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007713 |
|---|---|
| Receipt number | R000009092 |
| Scientific Title | Assessment of the treatment effect of pregabalin in patients with post-thoracotomy pain |
| Date of disclosure of the study information | 2012/04/10 |
| Last modified on | 2016/12/15 02:40:47 |
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Basic information
Public title
Assessment of the treatment effect of pregabalin in patients with post-thoracotomy pain
Acronym
Assessment of the treatment effect of pregabalin in patients with post-thoracotomy pain
Scientific Title
Assessment of the treatment effect of pregabalin in patients with post-thoracotomy pain
Scientific Title:Acronym
Assessment of the treatment effect of pregabalin in patients with post-thoracotomy pain
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of pregabalin 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 at week 2 (Pain at rest, or at coughing)
Key secondary outcomes
1) VAS at day 0 to 7, week 4 and month 3 (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 (Short-Form McGill Pain Questionnaire) at day 0 and 7, week 2 and 4, and month 3
4) EQ-5D at day 0 to 7, week 2, and 4, and month 3
5) Sleep disorder score (VAS)
6) Incidence of adverse reactions: sleepiness, lightheaded feeling, edema, nausea, vomiting, constipation, and other
7) Number of rescue medication use (codeine phosphate powder 20mg/time and Acetaminophen 400mg/time)
8) Screening 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
Control group (Standard treatment group): The following treatments for 2 weeks
- Codeine phosphate powder 20mg, TID
- Acetaminophen 400mg, TID
Interventions/Control_2
Study treatment group (Pregabalin group):
The following treatments for 2 weeks
- Codeine phosphate powder 20mg, TID
- Acetaminophen 400mg, TID
- Pregabalin 75mg, BID
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 received thoracotomy
2. Patients who complain of post-thoracotomy pain after 2-day epidural anesthesia (VAS>=40)
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. Patient who used opioid, 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
mcbyq256@yahoo.co.jp
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
mcbyq256@yahoo.co.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine
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
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
| 2012 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2016 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009092
