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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002275
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Orthopaedic Surgery, Sappro Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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