UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002275 |
|---|---|
| Receipt number | R000002783 |
| Scientific Title | Axillary block and local anesthesia for postoperative pain control after elbow arthroscopy: A randomized controlled trial |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2014/01/31 11:05:22 |
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Basic information
Public title
Axillary block and local anesthesia for postoperative pain control after elbow arthroscopy: A randomized controlled trial
Acronym
Clinical trial on the effectiveness of axillary block and local anesthesia
Scientific Title
Axillary block and local anesthesia for postoperative pain control after elbow arthroscopy: A randomized controlled trial
Scientific Title:Acronym
Clinical trial on the effectiveness of axillary block and local anesthesia
Region
| Japan |
Condition
Condition
Elbow disorders for which elbow arthroscopic surgery is indicated
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of axillary block with local anesthesia for the management of pain in patients undergoing elbow arthroscopic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores on a visual analog pain scale administered postoperative 24 hours
Key secondary outcomes
Scores on a visual analog pain scale at rest and during physiotherapy, sensory and motor blockade, complications, and patient satisfaction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The axillary block is performed with use of an 18G insulated Tuohy needle connected to a nerve stimulator. After the stimulating introducing needle is properly positioned, 20ml of 0.375% ropivacaine is injected. This is followed by general anesthesia.
Interventions/Control_2
After general anesthesia, total 10ml of epinephrine added 1% lidocaine is administered to portal skin incisions.
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
Elbow disorders for which elbow arthroscopic surgery is indicated.
Key exclusion criteria
allergy to local anesthetics
peripheral neuropathy except entrapment neuropathy
proven opioid dependency
dementia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuro Wada |
Organization
Sapporo Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
South 1, West 16, Chuo-ku, Sapporo
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Wada |
Organization
Sapporo Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Orthopaedic Surgery, Sappro Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Sapporo Medical University
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
| 2009 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24439245
Number of participants that the trial has enrolled
Results
Postoperative pain levels after arthroscopic elbow surgery could be well managed with oral analgesics. An axillary nerve block was not found to provide any postoperative pain control benefits.
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
| 2009 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 31 | Day |
Last modified on
| 2014 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002783
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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