UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014515 |
|---|---|
| Receipt number | R000016471 |
| Scientific Title | Evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after thoracotomy in patients with lung cancer |
| Date of disclosure of the study information | 2014/07/09 |
| Last modified on | 2015/01/09 12:34:07 |
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Basic information
Public title
Evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after thoracotomy in patients with lung cancer
Acronym
Evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after thoracotomy in patients with lung cancer
Scientific Title
Evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after thoracotomy in patients with lung cancer
Scientific Title:Acronym
Evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after thoracotomy in patients with lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Neuropathic Pain
Postoperative shoulder pain
Classification by specialty
| Chest surgery | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this comparative trail was to test whether the addition of pregabalin 150 mg/day (the maximum dose is 300 mg/day) in to the treatment of shoulder pain in patients who had undergone thoracic surgery for lung cancer would have a significant impact on the Visual Analog Scale (VAS) scores.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shoulder pain severity was measured using a 100-mm visual analog scale (VAS) scoring system until post operative days 7.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients received pregabalin 150 mg po 10-16 h after surgery and then non-steroidal anti-inflammatory drugs (NSAIDs) po 2 hours later. (maximum dose is 300 mg/day)
Interventions/Control_2
only NSAIDs po (loxoprofen 180mg/day)
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)Histologically or cytologically confirmed lung cancer
2)without indication for curative radiation therapy
3)Performance Status(ECOG) 0-1
4)Patients aged 20 years or older
5)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following
criteria
*Leukocyte counts >= 3,000/mm3
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0 g/dL
*AST and ALT, x 2.5 of upper limit of
normal (ULN) or less.
*Total bilirubin <=1.5mg/dL.
*Serum creatinin, x 1.5 of ULN or less.
*Electrocardiogram Nomal
*SpO2 >=90% or SaPO2 >=65mmHg
*Protein urea >= 1+
6)Patients providing written informed consent
Key exclusion criteria
Inappropriate patients for this study judged by the physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Imai |
Organization
Akita University Graduate School of Medicine
Division name
General Thoracic Surgery (and Breast & Endocrine Surgery)
Zip code
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6132
i-karo@mui.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Imai |
Organization
Akita University Graduate School of Medicine
Division name
General Thoracic Surgery (and Breast & Endocrine Surgery)
Zip code
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6132
Homepage URL
i-karo@mui.biglobe.ne.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Akita University Graduate School of Medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 09 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2014 | Year | 07 | Month | 09 | Day |
Last modified on
| 2015 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016471
