- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02383134
Maximal Distance for Successful Supraclavicular Block
The Maximum Effective Needle-to-Nerve Distance for Anesthetic Ultrasound-Guided Supraclavicular Brachial Plexus Block
The achievement of peripheral nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound.
The ultrasound guided supraclavicular brachial plexus block is known to be at risk of pneumothorax and / or nerve injury.
This study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ASA physical status I-III
- 18-85 years of age, inclusive
- surgery less than 3 hours
Exclusion Criteria:
- contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- existing neurological deficit in the area to be blocked
- pregnancy
- history of neck surgery or radiotherapy
- inability to understand the informed consent and demands of the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Success of the ultrasound guided supraclavicular block at 30 minutes after injection at a specific distance of the needle tip from the outer sheeth of the nerve
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
•The onset time of sensory and motor block
Time Frame: the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin
|
the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin
|
|
The proportion of inadequate and failed blocks.
Time Frame: the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin
|
the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin
|
|
The presence of other complications such as hematoma, infection, pneumothorax.
Time Frame: up to 48 hours post operative.
|
up to 48 hours post operative.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TunisianMH
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