UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039006 |
|---|---|
| Receipt number | R000037610 |
| Scientific Title | Continuous infusion of low-dose remifentanil for palliation of pain with Brachial plexus nerve block |
| Date of disclosure of the study information | 2019/12/26 |
| Last modified on | 2019/12/26 14:20:55 |
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Basic information
Public title
Continuous infusion of low-dose remifentanil for palliation of pain with Brachial plexus nerve block
Acronym
Remifentanil for palliation of pain with Brachial plexus nerve block
Scientific Title
Continuous infusion of low-dose remifentanil for palliation of pain with Brachial plexus nerve block
Scientific Title:Acronym
Remifentanil for palliation of pain with Brachial plexus nerve block
Region
| Japan |
Condition
Condition
humerus fracture
forearm fracture
clavicle fracture
shoulder periarthritis
rotator cuff tear
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
prospectively determine the safety and effectiveness of continuous infusion of low-dose remifentanil for the reduction of pain for patients with brachial plexus nerve block
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual analog scale (VAS) scores for pain after brachial plexus nerve block
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
none of remifentanil
Interventions/Control_2
0.02microgram/kg/min of remifentanil
Interventions/Control_3
0.05microgram/kg/min of remifentanil
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
| 12 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients having elective orthopedic surgery who required general anesthesia and interscalene brachial plexus block.
Key exclusion criteria
patients who can not obtain understanding of this study.
patients with allergy to remifentanilor other local anesthetic.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nana |
| Middle name | |
| Last name | Mine |
Organization
Saiseikai Futsukaichi Hospital
Division name
Department of Anesthesiology
Zip code
840-0021
Address
7-26-18 Onimaru, Saga city, Saga 840-0021, Japan
TEL
090-9568-0592
nanakikukawa@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Maeda |
Organization
Saiseikai Futsukaichi Hospital
Division name
Department of Anesthesiology
Zip code
840-0202
Address
4103 Kutii, Yamato-town, Saga city, Saga 840-0202, Japan
TEL
09053894872
Homepage URL
maeyan0222@yahoo.co.jp
Sponsor or person
Institute
Saiseikai Futsukaichi Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Futsukaichi Hospital
Address
3-13-1 Yu-machi, Chikushino city, Fukuoka 818-8516, Japan
Tel
092-923-1551
maeyan0222@yahoo.co.jp
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
| 2019 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037610
