UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007757 |
|---|---|
| Receipt number | R000008339 |
| Scientific Title | Impact of pregabalin in chronic neuropathic pain after lung resection |
| Date of disclosure of the study information | 2012/04/14 |
| Last modified on | 2014/03/17 16:58:25 |
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Basic information
Public title
Impact of pregabalin in chronic neuropathic pain after lung resection
Acronym
Impact of pregabalin in chronic neuropathic pain after lung resection
Scientific Title
Impact of pregabalin in chronic neuropathic pain after lung resection
Scientific Title:Acronym
Impact of pregabalin in chronic neuropathic pain after lung resection
Region
| Japan |
Condition
Condition
All diseases required lung resection
Classification by specialty
| Pneumology | Surgery in general | Chest surgery |
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the pregabalin in early postopeative period reduce the risk of chronic pain and pain-related complication.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale on post-operative three month
Key secondary outcomes
# Visual Analogue Scale on one week, two week, one month, two month after operation
# Respiratory function by spirometry on one month, two month, three month after operation.
# Checking if a patient has dry cough on one week, two week, one month, two month, three month after operation
# Cough medicine on one week, two week, one month, two month, three month after operation
# Athene ansomina scale on one week, two week, one month, two month, three month after operation
# Hospital periods after operation
# Side effect
# The number of pain rescue
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control group
pain control with loxoprofen and epidural anesthesia
1) Loxoprofen dose
180mg for daily total dose, 60mg for a dose
2) Epidural anesthesia
using fentanil, ropivacaine and saline
Interventions/Control_2
Pregabaline group
pain control drugs for control group plus pregabaline
1) Duration
Taking pregabaline on postoperative days 2 to 3 months
2) Pregabaline dose
50mg for starting daily total dose, 25mg for a dose
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with resected lung
Key exclusion criteria
# estimated glomerular filtration rate 30 ml/min and under
# median sternotomy approach
# preoperative neuropathic pain
# pneumonectomy
# severe complication (ex. heart failure, renal failure, hepatic failure, ileus)
# a woman during pregnancy or lactation, at risk fo becoming pregnant and desired pregnancy by a partner
# with psychiatric disorder and difficulty of participation
# attending judgement as inappropriateness of participation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Doki |
Organization
University of Toyama
Division name
Department of General Thoracic and Cardiovascular Surgery
Zip code
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Toyama
Division name
Department of General Thoracic and Cardiovascular Surgery
Zip code
Address
2630 Sugitani, Toyama, Toyama
TEL
076-434-7330
Homepage URL
Sponsor or person
Institute
Department of General Thoracic and Cardiovascular Surgery, University of Toyama
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2011 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 14 | Day |
Last modified on
| 2014 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008339
