UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013189 |
|---|---|
| Receipt number | R000015380 |
| Scientific Title | Randomized study comparing epidural anesthesia and pregabalin for perioperative pain control after thoracotomy |
| Date of disclosure of the study information | 2014/02/18 |
| Last modified on | 2018/03/01 09:47:29 |
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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
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
| 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
03-3964-1231
matsutan@med.teikyo-u.ac.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
03-3964-1231
Homepage URL
matsutan@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
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)
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
| 2014 | Year | 02 | Month | 18 | 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 | 08 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015380
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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