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

Regional Anaesthesia Clinical Trial

Official title:

Comparison of Intraneural and Extraneural Young's Modulus Using Shear Wave Elastography in Patients Undergoing Regional Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903369
• Other study ID #: Tenovus 13/7
• Status: Completed
• Start date: September 25, 2014
• Est. completion date: July 10, 2015

Study information

• Verified date: May 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 10, 2015
• Est. primary completion date: March 26, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Regional Anaesthesia

Intervention

Device:
• Shear Wave Elastography
Shear wave elastography

Locations

Country	Name	City	State
United Kingdom	Department of Anaesthesia, Ninewells Hospital & Medical School	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Arda K, Ciledag N, Aktas E, Aribas BK, Köse 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. — View Citation

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. — View Citation

Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: Reg Anesth Pain Med. 2010 May-Jun;35(2):325. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in stiffness between nerves and surrounding tissue in patients when using shear wave measurement before regional anaesthesia.	Youngs modulus	One visit per patient 45 mins