UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011406 |
|---|---|
| Receipt number | R000013351 |
| Scientific Title | Postoperative pain relief after ultrasound-guided axillary brachial plexus block: A randomized, double-blinded comparison between levobupivacaine and levobupivacaine with dexamethason. |
| Date of disclosure of the study information | 2013/08/07 |
| Last modified on | 2013/08/07 16:27:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Postoperative pain relief after ultrasound-guided axillary brachial plexus block: A randomized, double-blinded comparison between levobupivacaine and levobupivacaine with dexamethason.
Acronym
Postoperative pain relief after ultrasound-guided axillary brachial plexus block: A randomized, double-blinded comparison between levobupivacaine and levobupivacaine with dexamethason.
Scientific Title
Postoperative pain relief after ultrasound-guided axillary brachial plexus block: A randomized, double-blinded comparison between levobupivacaine and levobupivacaine with dexamethason.
Scientific Title:Acronym
Postoperative pain relief after ultrasound-guided axillary brachial plexus block: A randomized, double-blinded comparison between levobupivacaine and levobupivacaine with dexamethason.
Region
| Japan |
Condition
Condition
Fracture of the distal radius
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the postoperative pain relief by ultrasound-guided axillary brachial plexus block using levobupivacaine and levobupivacaine with dexamethason.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time when patients required an initial analgesic postoperatively.
The value of VAS at the time of leaving the operating room.
The value of VAS at the time the pain appeared.
The value of VAS at the time of using analgesics.
The value of VAS at the time of the next morning of surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.5 % levobupivacaine 20 ml with dexamethasone 6.6 mg is administered for ultrasound-guided axillary plexus block.
Interventions/Control_2
0.5 % levobupivacaine 20 ml with saline 2 ml is administered for ultrasound-guided axillary plexus block.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient scheduled for osteosynthesis of distal radius and who underwent ultrasound-guided axillary brachial plexus block
Key exclusion criteria
Patients who received corticosteroids or opioids, Patients with neuropathy in the affected side, Diabetes, Mental illness, Dementia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Moriya |
Organization
Fukuseikai Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-2-36, Noke, Sawara-ku, Fukuoka City, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukuseikai Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-2-36, Noke, Sawara-ku, Fukuoka City, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology, Fukuseikai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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 | 08 | Month | 07 | 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
| 2013 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2014 | Year | 07 | 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
| 2013 | Year | 08 | Month | 07 | Day |
Last modified on
| 2013 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013351
