UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006871 |
|---|---|
| Receipt number | R000008120 |
| Scientific Title | Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain |
| Date of disclosure of the study information | 2011/12/12 |
| Last modified on | 2018/09/14 20:22:44 |
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Basic information
Public title
Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Acronym
Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Scientific Title
Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Scientific Title:Acronym
Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Region
| Japan |
Condition
Condition
an upper abdominal surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients undergoing elective upper abdominal surgery in the operating room at Kawasaki University Hospital, a novel disposable PCA device that has just been launched from Daiken Medical Co., Ltd., will be used for epidural postoperative pain control to study the efficacy of the new device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Wound pain level (resting and moving VAS)
Number of requests for PCA and actual number of administrations
Total local anesthetic dose
Use of rescue drugs (drug, number of administrations and dose)
Key secondary outcomes
Patient backgrounds such as age and sex, etc.
Factors related to surgery, such as type, duration and bleeding volume etc.
Insertion site and length, etc. in epidural anesthesia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The novel 200 mL disposable PCA device or will be used as a postoperative PCA
pump.
Interventions/Control_2
A mechanical PCA devise will be used as a postoperative PCA pump.
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 aged 20 to 80 years who undergo an elective upper abdominal surgery
in the operating room and are at Grade I or II in preoperative patient status (ASA PS)
defined by American Society of Anesthesiologist (those who has no significant problem in
systemic preoperative status).
Key exclusion criteria
Patients who are considered ineligible for participation in the present study by the attending physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Nakatsuka |
Organization
Kawasaki Medical University
Division name
Department of Anesthesiology & Intensive Care Medicine 2
Zip code
Address
577 Matsushima, Kurashiki-City, Okayama 701-0192 Japan
TEL
086-462-1111
hideki@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Nakatsuka |
Organization
Kawasaki Medical University
Division name
Department of Anesthesiology & Intensive Care Medicine 2
Zip code
Address
577 Matsushima, Kurashiki-City, Okayama 701-0192 Japan
TEL
086-462-1111
Homepage URL
hideki@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical University
Department of Anesthesiology & Intensive Care Medicine 2
Institute
Department
Personal name
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
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
川崎医科大学附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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 | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 11 | Day |
Last modified on
| 2018 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008120
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
