UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the treatment effect of pregabalin in patients with post-thoracotomy pain
Title of the study (Brief title)	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	Hiroki Iida
Organization	Gifu University Graduate School of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Address	1-1 Yanagido, Gifu City, Gifu, 501-1194
TEL	058-230-6404
Email	mcbyq256@yahoo.co.jp

Public contact
Name of contact person	Noritaka Yoshimura
Organization	Gifu University Graduate School of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Address	1-1 Yanagido, Gifu City, Gifu, 501-1194
TEL	058-230-6404
Homepage URL
Email	mcbyq256@yahoo.co.jp

Sponsor
Institute	Gifu University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009092