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 |
Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Study of the Efficacy of a Novel Disposable Patient-Controlled Analgesia Device in Postoperative Pain
Japan |
an upper abdominal surgery
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Anesthesiology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
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)
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Device,equipment |
The novel 200 mL disposable PCA device or will be used as a postoperative PCA
pump.
A mechanical PCA devise will be used as a postoperative PCA pump.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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).
Patients who are considered ineligible for participation in the present study by the attending physician.
60
1st name | |
Middle name | |
Last name | Hideki Nakatsuka |
Kawasaki Medical University
Department of Anesthesiology & Intensive Care Medicine 2
577 Matsushima, Kurashiki-City, Okayama 701-0192 Japan
086-462-1111
hideki@med.kawasaki-m.ac.jp
1st name | |
Middle name | |
Last name | Hideki Nakatsuka |
Kawasaki Medical University
Department of Anesthesiology & Intensive Care Medicine 2
577 Matsushima, Kurashiki-City, Okayama 701-0192 Japan
086-462-1111
hideki@med.kawasaki-m.ac.jp
Kawasaki Medical University
Department of Anesthesiology & Intensive Care Medicine 2
None
Other
NO
川崎医科大学附属病院(岡山県)
2011 | Year | 12 | Month | 12 | Day |
Unpublished
Completed
2011 | Year | 12 | Month | 11 | Day |
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2011 | Year | 12 | Month | 11 | Day |
2018 | Year | 09 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008120