UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039952 |
|---|---|
| Receipt number | R000045555 |
| Scientific Title | The effectiveness of variable-rate feedback infusion using dual channel elastomeric pump for intravenous patient-controlled analgesia in the patients with traumatic fractures: a randomized, double-blind, prospective study |
| Date of disclosure of the study information | 2020/03/26 |
| Last modified on | 2020/03/26 14:19:31 |
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Basic information
Public title
The effectiveness of variable-rate feedback infusion using dual channel elastomeric pump for intravenous patient-controlled analgesia in the patients with traumatic fractures: a randomized, double-blind, prospective study
Acronym
Efficacy of dual channel IV-PCA in trauma patients
Scientific Title
The effectiveness of variable-rate feedback infusion using dual channel elastomeric pump for intravenous patient-controlled analgesia in the patients with traumatic fractures: a randomized, double-blind, prospective study
Scientific Title:Acronym
Efficacy of dual channel IV-PCA in trauma patients
Region
| Asia(except Japan) |
Condition
Condition
Trauma adult patients (20-64 years) undergoing orthopedic surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
variable-rate feedback infusion vs constant-rate infusion in dual channel IV-PCA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Opioid(fentanyl) consumption after surgery (post-op 6, 12, 24, 36, 48 hours)
Key secondary outcomes
Pain score(Verbal numeric rating scale)
rescue analgesic (ketorolac)
patient satisfaction
recovery scores including RASS, CAM-ICU and PARS
adverse events including PONV
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions:
Fentanyl based PCA in both "continuos channel (constant flow channel; fentanyl 10 ug/kg + ramosetron 0.3mg, total 100ml, 2ml/hr)" and "Selector & bolus channel (adjustable flow channel;fentanyl 10 ug/kg + ramosetron 0.3mg, total 100ml, 1(0-2)ml/hr)"
Interventions/Control_2
Control:
Fentanyl based PCA in both "continuos channel (constant flow channel; fentanyl 10 ug/kg + ramosetron 0.3mg, total 100ml, 2ml/hr)" and "continuous & bolus channel (another constant flow channel;fentanyl 10 ug/kg + ramosetron 0.3mg, total 100ml, 1 ml/hr)"
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA I-III traumatic patients expecting a scheduled orthopedic surgery
Key exclusion criteria
BMI at or above 35, drug abuse, allergy history in fentanyl and ramosetron, dementia, psychiatric disease, communication problem, severe chronic pain, and incapable of decision making
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Young Sung |
| Middle name | |
| Last name | Kim |
Organization
Korea University Guro Hospital
Division name
Department of Anesthesiology and Pain medicine
Zip code
08308
Address
148, Gurodong-ro, Guro-gu, Seoul, Korea
TEL
82-2-2626-1437
stelios@naver.com
Public contact
Name of contact person
| 1st name | Young Sung |
| Middle name | |
| Last name | Kim |
Organization
Korea University Guro Hospital
Division name
Department of Anesthesiology and Pain medicine
Zip code
08308
Address
148, Gurodong-ro, Guro-gu, Seoul, Korea
TEL
82-2-2626-1437
Homepage URL
https://guro.kumc.or.kr
stelios@naver.com
Sponsor or person
Institute
Korea University Guro Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Korea
Other related organizations
Co-sponsor
Not applicable
Name of secondary funder(s)
Not applicable
IRB Contact (For public release)
Organization
Korea University Guro Hospital
Address
148, Gurodong-ro, Guro-gu, Seoul, Korea
Tel
82-2-2626-1632
eirbadmin@kumc.or.kr
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
Korea University Guro Hospital(Seoul,Korea)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045555
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
