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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02266732
Other study ID # AN11/9771
Secondary ID 11/YH/0206
Status Completed
Phase N/A
First received October 3, 2014
Last updated February 19, 2015
Start date May 2011
Est. completion date June 2011

Study information

Verified date February 2015
Source The Leeds Teaching Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Stimuplex HNS 12


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Five minutes No
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