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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010661
Receipt No. R000012402
Scientific Title A clinical study on appropriate pain control using IVPCA with fentanyl.
Date of disclosure of the study information 2013/06/01
Last modified on 2015/05/10

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Basic information
Public title A clinical study on appropriate pain control using IVPCA with fentanyl.
Acronym The postoperative pain control using IVPCA with fentanyl.
Scientific Title A clinical study on appropriate pain control using IVPCA with fentanyl.
Scientific Title:Acronym The postoperative pain control using IVPCA with fentanyl.
Region
Japan

Condition
Condition Laparoscopic cholecystectomy
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find a condition of most suitable IVPCA including an evaluation and side effect precaution in the preoperation of the patient and aim at better patient perioperative care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative visual analog pain score (VAS)
Key secondary outcomes Intravenous-Patient-controlled analgesia (IV-PCA) requirements for postoperative 48 h, patient's satisfaction, side effects (heart rate, blood pressure, SpO2, breathing, sedation score)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 IVPCA: Fentanyl 18ml with saline 42ml for postoperative 24hr
Interventions/Control_2 IVPCA: Fentanyl 32mlwith saline 28ml for postoperative 24hr
Interventions/Control_3 PCEA: ropivacain2mg/ml for postoperative 24hr
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 1)Over 20 years old, less than 80 years
2)Patients undergoing laparoscopic cholecystectomy
3)ASA-PS 1-2
4)Obtained written informed consent
Key exclusion criteria 1 )ASA class >3.
2) Patient with the drug allergy
3) Pregnant woman, breast-feeding woman or possibility of pregnancy
4) QT elongation on preoperative electrocardiogram (ECG) assessment
5) Judged as unsuitable for this study
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Sakamoto
Organization Nippon medical school hospital
Division name Department of Anesthesiology
Zip code
Address 1-1-5 Sendagi, bunkyo-ku, Tokyo
TEL 03-3822-2131
Email no1-saka@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroe Onaka
Organization Nippon medical school hospital
Division name Department of Anesthesiology
Zip code
Address 1-1-5 Sendagi, bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email honaka@nms.ac.jp

Sponsor
Institute Nippon Medical School
Department of Anesthesiolgy
Institute
Department

Funding Source
Organization Nippon Medical School
Department of Anesthesiolgy
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 06 Month 01 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
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 07 Day
Last modified on
2015 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012402

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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