UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010661 |
|---|---|
| Receipt number | 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 22:43:46 |
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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
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
honaka@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Department of Anesthesiolgy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012402
