UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy
Title of the study (Brief title)	Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy
Region	Japan

Condition
Condition	thoracotomy
Classification by specialty	Chest surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate a novel method for perioperative pain control by conducting a comparative study to assess the efficacy and safety of epidural anesthesia and pregabalin after thoracotomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Pain score (NRS) on the first postoperative day (1 POD NRS)
Key secondary outcomes	Pain score (NRS) on the third and fifth postoperative day (3, 5 POD NRS) Frequency of analgesic drug use for pain control Sleep disorder score on the first, third, and fifth postoperative day Occurrence rate and severity of adverse effects Time periods of anesthesia in preparation for and during surgery

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	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	-Initial medication on the day of surgery: Oral administration of 400mg of celecoxib and 75mg of pregabalin -Medication 6 hours after administering initial dose: Oral administration of 200mg of celecoxib and 75mg of pregabalin -Medication one day after surgery: Oral administration of 200mg celecoxib 2T 2x (morning and evening) and 75mg of pregabalin 2T 2x (morning, evening)
Interventions/Control_2	-Initial medication on the day of surgery:Oral administration of 400mg of celecoxib -Medication 6 hours after administering initial dose: Oral administration of 200mg of celecoxib -During surgery: Pain control by epidural anesthesia with continuing administration of 0.2% ropivacaine hydrochloride and fentanyl for 48 hours after surgery -Medication one day after surgery: Oral administration of 200mg celecoxib 2T 2x (morning and evening)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with PS 0 or 1 (ECOG) patients undergoing thoracotomy requiring manipulation intercostals and ribs patients with normal kidney function with creatinine clearance (Ccr, hereafter) >30ml/min patients who have signed the consent form to participate in this study
Key exclusion criteria	(1) patients who are taking antidepressants, anti-seizure drugs, and/or opioids prior to surgery (2) patients with serious complications (such as uncontrollable heart, lung, liver or kidney disease, and diabetes) (3) patients with a history of angioedema (4) female patients who are pregnant, nursing, or might be pregnant (voluntary) (5) patients who are problematic in receiving epidural anesthesia (such as patients with spinal deformity and patients undergoing treatment with anticoagulants) (6) patients considered unsuitable for the study by a primary physician
Target sample size	96

Research contact person
Name of lead principal investigator	Noriyuki Matsutani
Organization	Teikyo university school of medicine
Division name	Surgery
Address	2-11-1 Kaga, Itabashi-ku Tokyo Japan
TEL	03-3964-1231
Email	matsutan@med.teikyo-u.ac.jp

Public contact
Name of contact person	Noriyuki Matsutani
Organization	Teikyo University School of Medicine
Division name	Surgery
Address	2-11-1 Kaga, Itabashi-ku Tokyo Japan
TEL	03-3964-1231
Homepage URL
Email	matsutan@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Pfizer inc
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2015 Year 06 Month 30 Day
Date of closure to data entry	2015 Year 06 Month 30 Day
Date trial data considered complete	2015 Year 06 Month 30 Day
Date analysis concluded	2015 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 18 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015380