UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026417 |
|---|---|
| Receipt number | R000030346 |
| Scientific Title | Perineural dexmedetomidine prolong the duration of analgesia: RCT |
| Date of disclosure of the study information | 2017/03/06 |
| Last modified on | 2021/04/19 09:15:12 |
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Basic information
Public title
Perineural dexmedetomidine prolong the duration of analgesia: RCT
Acronym
DEX adjuvant local alagesic: RCT
Scientific Title
Perineural dexmedetomidine prolong the duration of analgesia: RCT
Scientific Title:Acronym
DEX adjuvant local alagesic: RCT
Region
| Japan |
Condition
Condition
the patients received trunk block
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to confirm that addition of dexmedetomidine will prolong the duration of analgesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
first report of postoperative pain at the surgical site
Key secondary outcomes
opioid comsumption, VAS, QOR-40,
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.3% levobupivacaine+dexmedetomidine 1micro g/kg
Interventions/Control_2
0.3% levobupivacaine+NS
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
20-75 year old patients
Key exclusion criteria
patients intaking coagulation drug
severe disease patietns
patients we determine as unsuitability
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Yoshimura |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-1 Kodacho, Shunan, Yamaguchi 745-8522, Japan.
TEL
0834-28-4411
manabu-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manbabu Yoshimura |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-1 Kodacho, Shunan, Yamaguchi 745-8522, Japan.
TEL
0834-28-4411
Homepage URL
manabu-ygc@umin.ac.jp
Sponsor or person
Institute
Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
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
| 2017 | Year | 03 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2018 | 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
| 2017 | Year | 03 | Month | 06 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030346
