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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007757
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of General Thoracic and Cardiovascular Surgery, University of Toyama
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008339

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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