Back to resultsUltrasound Vs Nerve Stimulation - Why is a PNS so Effective?
Primary Purpose
Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stimuplex HNS 12
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Interscalene block
Femoral block
Arm Description
Outcomes
Primary Outcome Measures
Nerve stimulation resulting in muscle contraction or not
Whether the nerve is successfully stimulated, resulting in muscle contraction, or not when the needle is on the wrong side of the fascial layer.
Secondary Outcome Measures
Full Information
NCT ID
NCT02266732
First Posted
October 3, 2014
Last Updated
February 19, 2015
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02266732
Brief Title
Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?
Official Title
Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interscalene block
Arm Type
Other
Arm Title
Femoral block
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Stimuplex HNS 12
Other Intervention Name(s)
Peripheral nerve stimulator for nerve location
Primary Outcome Measure Information:
Title
Nerve stimulation resulting in muscle contraction or not
Description
Whether the nerve is successfully stimulated, resulting in muscle contraction, or not when the needle is on the wrong side of the fascial layer.
Time Frame
Five minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?
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