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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026336
Receipt No. R000014902
Scientific Title Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy
Date of disclosure of the study information 2017/03/01
Last modified on 2018/03/01

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Basic information
Public title Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy
Acronym Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy
Scientific Title Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy
Scientific Title:Acronym Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy
Region
Japan

Condition
Condition patients undergoing thoracotomy requiring manipulation intercostals and ribs
Classification by specialty
Surgery in general 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 Exploratory
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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Epidural anesthesia group
-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_2 Pregabalin group
-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_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 patients who are taking antidepressants, anti-seizure drugs, and/or opioids prior to surgery
patients with serious complications (such as uncontrollable heart, lung, liver or kidney
disease, and diabetes)
patients with a history of angioedema
female patients who are pregnant, nursing, or might be pregnant (voluntary)
patients who are problematic in receiving epidural anesthesia (such as patients with spinal deformity and patients undergoing treatment with anticoagulants)
patients considered unsuitable for the study by a primary physician
Target sample size 96

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Matsutani
Organization Teikyo University School of Medicine
Division name Surgery
Zip code
Address 2-11-1 Kaga, Itabashi-ku Tokyo Japan
TEL +81-3-3964-1231
Email matsutani1970@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Matsutani
Organization Teikyo University School of Medicine
Division name Surgery
Zip code
Address 2-11-1 Kaga, Itabashi-ku Tokyo, Japan
TEL +81-3-3964-1231
Homepage URL http://teikyohaigeka.com/
Email matsutan@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Pfizer
Organization
Division
Category of Funding Organization Profit organization
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 帝京大学医学部外科

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 01 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
2013 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 06 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
2017 Year 02 Month 28 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/ctr_e/ctr_view.cgi?recptno=R000014902

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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