- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442558
Comparison of Quality of Supraclavicular, Infraclavicular and Axillary Approach of Ultrasound-guided Brachial Plexus Block
January 20, 2015 updated by: Hillel Yaffe Medical Center
The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial plexus blocks for surgical anesthesia
Study Overview
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I-III physical status
- Surgery of distal arm, forearm or hand
Exclusion Criteria:
- Skin infection near block injection site
- Allergy to local anesthetics
- Peripheral neuropathy upper limb
- INR of more than 1.4
- Thrombocytopenia
- Opioid dependency
- Chronic pain syndrome
- Lack of orientation to person, place and time
- Patient refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SCL
Supraclavicular ultrasound-guided brachial plexus block
|
Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.
|
Active Comparator: ICL
Infraclavicular ultrasound-guided brachial plexus block
|
Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.
|
Active Comparator: AX
Axillary ultrasound-guided brachial plexus block
|
Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of 3 different approaches to brachial plexus block
Time Frame: Immediate
|
Whether or not there is need for additional analgesic drugs or need to switch to general anesthesia
|
Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
September 22, 2011
First Submitted That Met QC Criteria
September 27, 2011
First Posted (Estimate)
September 28, 2011
Study Record Updates
Last Update Posted (Estimate)
January 21, 2015
Last Update Submitted That Met QC Criteria
January 20, 2015
Last Verified
September 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0081-2011-HYMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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