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

NCT ID: NCT01903369

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-25

Study Completion Date

2015-07-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Regional Anaesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Elective orthopaedic surgery patients

All patients presenting for elective orthopaedic surgery \>16 years of age.

Shear Wave Elastography

Intervention Type DEVICE

Shear wave elastography

Interventions

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Shear Wave Elastography

Shear wave elastography

Intervention Type DEVICE

Other Intervention Names

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Siemens 3000 shear wave utrasound machine

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Graeme A McLeod, MBChB FRCA

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside

Locations

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Department of Anaesthesia, Ninewells Hospital & Medical School

Dundee, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.

Reference Type BACKGROUND
PMID: 14667752 (View on PubMed)

Neal JM, Brull R, Chan VW, Grant SA, Horn JL, Liu SS, McCartney CJ, Narouze SN, Perlas A, Salinas FV, Sites BD, Tsui BC. The ASRA evidence-based medicine assessment of ultrasound-guided regional anesthesia and pain medicine: Executive summary. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S1-9. doi: 10.1097/AAP.0b013e3181d22fe0.

Reference Type BACKGROUND
PMID: 20216019 (View on PubMed)

Neal JM, Wedel DJ. Ultrasound guidance and peripheral nerve injury: is our vision as sharp as we think it is? Reg Anesth Pain Med. 2010 Jul-Aug;35(4):335-7. doi: 10.1097/AAP.0b013e3181e8a3bb. No abstract available.

Reference Type BACKGROUND
PMID: 20588150 (View on PubMed)

Liu SS, YaDeau JT, Shaw PM, Wilfred S, Shetty T, Gordon M. Incidence of unintentional intraneural injection and postoperative neurological complications with ultrasound-guided interscalene and supraclavicular nerve blocks. Anaesthesia. 2011 Mar;66(3):168-74. doi: 10.1111/j.1365-2044.2011.06619.x.

Reference Type BACKGROUND
PMID: 21320084 (View on PubMed)

Palmeri ML, Dahl JJ, MacLeod DB, Grant SA, Nightingale KR. On the feasibility of imaging peripheral nerves using acoustic radiation force impulse imaging. Ultrason Imaging. 2009 Jul;31(3):172-82. doi: 10.1177/016173460903100303.

Reference Type BACKGROUND
PMID: 19771960 (View on PubMed)

Wells PN, Liang HD. Medical ultrasound: imaging of soft tissue strain and elasticity. J R Soc Interface. 2011 Nov 7;8(64):1521-49. doi: 10.1098/rsif.2011.0054. Epub 2011 Jun 16.

Reference Type BACKGROUND
PMID: 21680780 (View on PubMed)

Evans A, Whelehan P, Thomson K, McLean D, Brauer K, Purdie C, Jordan L, Baker L, Thompson A. Quantitative shear wave ultrasound elastography: initial experience in solid breast masses. Breast Cancer Res. 2010;12(6):R104. doi: 10.1186/bcr2787. Epub 2010 Dec 1.

Reference Type BACKGROUND
PMID: 21122101 (View on PubMed)

Munirama S, Joy J, Eisma R, Corner G, Cochran S, McLeod G. Shear wave elastography: novel technology for ultrasound-guided regional anesthesia. Anesthesiology. 2013 Sep;119(3):698. doi: 10.1097/ALN.0b013e31827ddeb6. No abstract available.

Reference Type BACKGROUND
PMID: 23291624 (View on PubMed)

Arda K, Ciledag N, Aktas E, Aribas BK, Kose K. Quantitative assessment of normal soft-tissue elasticity using shear-wave ultrasound elastography. AJR Am J Roentgenol. 2011 Sep;197(3):532-6. doi: 10.2214/AJR.10.5449.

Reference Type BACKGROUND
PMID: 21862792 (View on PubMed)

Other Identifiers

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Tenovus 13/7

Identifier Type: -

Identifier Source: org_study_id

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