Comparison of Intraneural and Extraneural Young's Modulus... | NCT01903369

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

NCT01903369

Sponsor

University of Dundee

Status

Completed

Last Update Posted

May 6, 2019Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Regional Anaesthesia

Interventions

Shear Wave Elastography

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2014Actual

Primary Completion Date

Mar 26, 2015Actual

Completion Date

Jul 10, 2015Actual

First Submitted Date

Jul 11, 2013

First Submission Date that Met QC Criteria

Jul 16, 2013

First Posted Date

Jul 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2019

Last Update Posted Date

May 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elective orthopaedic surgery patients		All patients presenting for elective orthopaedic surgery >16 years of age.	Device: Shear Wave Elastography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Shear Wave Elastography	Device	Shear wave elastography	Elective orthopaedic surgery patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Graeme A McLeod, MBChB FRCA	NHS Tayside	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesia, Ninewells Hospital & Medical School		Dundee		DD19SY	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14667752	Background	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.
20216019	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.