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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011195
Receipt No. 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

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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 Obsterics 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
Email

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
Email

Sponsor
Institute Sapporo Medical University, School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013002

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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