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

NCT01903369 | Completed FDA Device

• 1 other identifier: Tenovus 13/7
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anaesthesia

Keywords

Shear wave; Elastography; Repeatability and Reproducibility

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Elective orthopaedic surgery patients

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

Device: Shear Wave Elastography

Interventions

Shear Wave Elastography DEVICE

Shear wave elastography

Also known as: Siemens 3000 shear wave utrasound machine

Elective orthopaedic surgery patients

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing routine ultrasound-guided regional anaesthesia for elective orthopaedic surgery at Ninewells Hospital \& Medical School, Dundee.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Department of Anaesthesia, Ninewells Hospital & Medical School

Dundee, DD19SY, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 14667752 BACKGROUND

• 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.

  PMID: 20216019 BACKGROUND

• 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.

  PMID: 20588150 BACKGROUND

• 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.

  PMID: 21320084 BACKGROUND

• 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.

  PMID: 19771960 BACKGROUND

• 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.

  PMID: 21680780 BACKGROUND

• 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.

  PMID: 21122101 BACKGROUND

• 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.

  PMID: 23291624 BACKGROUND

• 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.

  PMID: 21862792 BACKGROUND

Study Officials

• Graeme A McLeod, MBChB FRCA

  NHS Tayside

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 19, 2013
• Study Start: September 25, 2014
• Primary Completion: March 26, 2015
• Study Completion: July 10, 2015
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

GB (1)