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


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 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


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

Value
https://center6.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