UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011195 |
|---|---|
| Receipt number | R000013002 |
| Scientific Title | Comparison of IV-PCA of fentanyl and morphine in management of postoperative pain after abdominal surgery |
| Date of disclosure of the study information | 2013/07/20 |
| Last modified on | 2013/07/16 11:03:10 |
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Basic information
Public title
Comparison of IV-PCA of fentanyl and morphine in management of postoperative pain after abdominal surgery
Acronym
IV-PCA fentanyl vs. morphine
Scientific Title
Comparison of IV-PCA of fentanyl and morphine in management of postoperative pain after abdominal surgery
Scientific Title:Acronym
IV-PCA fentanyl vs. morphine
Region
| Japan |
Condition
Condition
major abdominal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the efficacy and adverse effects of fentanyl IV-PCA compared with morphine IV-PCA in patients after major abdominal surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain score
Additional analgesia
Adverse effects(nausea, sedation, respiratory dysfunction)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group Fentanyl(n=20)
Interventions/Control_2
Group Morphine(n=20)
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
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
After obtaining approval from the institutional review board of our hospital and written informed consent from each patient, 40 patients (American Society of Anesthesiologists physical status I-II) scheduled for elective major abdominal laparotomy under general anesthesia were enrolled in this study.
Key exclusion criteria
Patients were excluded if they were younger than 18 years or older than 80 years of age, had a history of allergy to opioids, had daily intake of opioids for a period of more than 1 week, had known or suspected drug abuse, were pregnant, or were unable to understand a pain scale or use a PCA device.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukitoshi Niiyama |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
outh 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
Homepage URL
Sponsor or person
Institute
Sapporo Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 07 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | 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
| 2013 | Year | 07 | Month | 16 | Day |
Last modified on
| 2013 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013002
