- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266732
Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?
February 19, 2015 updated by: The Leeds Teaching Hospitals NHS Trust
The traditional model of localizing a nerve for blockade is using a peripheral nerve stimulator, PNS.
Recent advances in UltraSound technology has allowed UltraSound to guide nerve blockade.
However despite excellent visualization nerve block success has not significantly improved.
I aim to show that this is because the PNS stimulation of a nerve is more than a proximity response as thought but a correct fascial plane response and hence the high success rate of this blind approach.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA 1 to 3 patients for any shoulder surgery or unilateral ACL knee surgery
Exclusion Criteria:
- Refusal to consent
- Allergy to Chirocaine local anaesthetic
- Pace maker in situ
- Sepsis at site of regional block
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Interscalene block
|
Other Names:
|
|
Other: Femoral block
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nerve stimulation resulting in muscle contraction or not
Time Frame: Five minutes
|
Whether the nerve is successfully stimulated, resulting in muscle contraction, or not when the needle is on the wrong side of the fascial layer.
|
Five minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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
May 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
October 3, 2014
First Submitted That Met QC Criteria
October 16, 2014
First Posted (Estimate)
October 17, 2014
Study Record Updates
Last Update Posted (Estimate)
February 23, 2015
Last Update Submitted That Met QC Criteria
February 19, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN11/9771
- 11/YH/0206 (Other Identifier: Research Ethics Committee)
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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