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Comparison of Intraneural and Extraneural Young's Modulus Using Shear Wave Elastography

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ClinicalTrials.gov Identifier: NCT01903369
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Dundee

Brief Summary:
The investigators would like to compare the stiffness inside and outside nerves using a special type of ultrasound imaging called shear wave elastography. Shear wave elastography is a special form of ultrasound as the pictures taken are in colour. An ultrasound machine has different ways of taking pictures of inside the body: one is by measuring the brightness of different body parts (often referred to as the B-Mode scan), the pictures taken in this way are the same as those you may have seen of unborn babies inside their mum's tummies; another way is by measuring the stiffness of different body structures which is how shear wave elastography works. The investigators hope that this new technology will help doctors to see the parts of the body that are important to them.

Condition or disease Intervention/treatment
Regional Anaesthesia Device: Shear Wave Elastography

Detailed Description:

Shear wave elastography is a quantitative ultrasound modality increasingly used to differentiate between "hard" breast cancer masses and "soft" normal tissue. Unlike strain elastography, shear wave elastography applies a non-compressive longitudinal acoustic radiation force to underlying tissues, inducing transverse shear waves. Studies in Thiel embalmed human cadavers have shown significant differences in Young's modulus between intraneural and extraneural tissue, and ready colour differentiation between tissues.

The investigators own pilot studies have shown a 3-fold greater Young's modulus within nerve in Thiel embalmed cadavers and human volunteers. The investigators hypothesis is that shear wave elastography can differentiate between nerve and adjacent tissue in patients before nerve block for surgery. If so, this technology has the potential to reduce the incidence of complications with UGRA and encourage parallel applications such as cancer node biopsy.


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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Comparison of Intraneural and Extraneural Young's Modulus Using Shear Wave Elastography in Patients Undergoing Regional Anaesthesia
Actual Study Start Date : September 25, 2014
Actual Primary Completion Date : March 26, 2015
Actual Study Completion Date : July 10, 2015

Group/Cohort Intervention/treatment
Elective orthopaedic surgery patients
All patients presenting for elective orthopaedic surgery >16 years of age.
Device: Shear Wave Elastography
Shear wave elastography
Other Name: Siemens 3000 shear wave utrasound machine




Primary Outcome Measures :
  1. The difference in stiffness between nerves and surrounding tissue in patients when using shear wave measurement before regional anaesthesia. [ Time Frame: One visit per patient 45 mins ]
    Youngs modulus



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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing routine ultrasound-guided regional anaesthesia for elective orthopaedic surgery at Ninewells Hospital & Medical School, Dundee.
Criteria

Inclusion Criteria:

  • All patients presenting for elective orthopaedic surgery >16 years of age.
  • ASA score 1, 2 or 3.
  • Capacity to provide informed consent.

Exclusion Criteria:

  • Patients not undergoing ultrasound guided regional anaesthesia.
  • ASA score 4 or above.
  • Patients without the capacity to provide informed consent.
  • Pregnant women.
  • Patients currently participating in another research project or patients who have participated in a research project in the 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903369


Locations
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United Kingdom
Department of Anaesthesia, Ninewells Hospital & Medical School
Dundee, United Kingdom, DD19SY
Sponsors and Collaborators
University of Dundee
Investigators
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Principal Investigator: Graeme A McLeod, MBChB FRCA NHS Tayside

Publications:

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Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT01903369     History of Changes
Other Study ID Numbers: Tenovus 13/7
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Dundee:
Shear wave
Elastography
Repeatability and Reproducibility