Can Ultrasound Predict Nerve Injury Following Posterior Tibial Nerve Block in Patients With Peripheral Neuropathy?

November 21, 2017 updated by: University Health Network, Toronto

The use of regional anesthesia for nerve block in diabetic patients with peripheral neuropathy is currently made on a case-by-case basis, also remains underlying uncertainty regarding the preferred technique and the likelihood of block-related nerve injury. For this many diabetic patients with otherwise healthy nerves may receive general anesthesia instead of regional anesthesia, thus giving up the benefits associated with the latter technique, including a decrease in health complications and superior analgesia following the operation. Ultrasound is used to identify the target nerve and guide needle insertion for nerve blocks, may be a useful tool to detect the presence and severity of neuropathy prior to block placement, a recent study demonstrated a statistically significant increase in the sonographic cross-sectional area of the posterior tibial nerve (PTN) in all diabetic patients who had abnormal motor transmission on nerve conduction studies. For regional anesthesiologists, the ultimate goal of detecting peripheral neuropathy and in particular, diabetic neuropathy by US is to avoid nerve injury. To do so, the association between US-detected diabetic neuropathy and block-related nerve damage must be first established, hence the purpose of this study. We aim to examine whether the cross-sectional area of PTN as assessed by preoperative US can predict nerve injury as assessed by worsening nerve conduction studies following PTN block inpatients scheduled to receive an ankle block. A further subgroup analysis will be performed in diabetic patients.

We hypothesize that the cross sectional area of the PTN will correlate with motor conduction velocity on nerve conduction studies (NCS) following PTN block in patients with peripheral neuropathy. All eligible patients will undergo NCS to confirm or exclude distal neuropathy. Patients without neuropathy will be excluded from further participation in this study. Also excluded will be diabetic patients with neuropathy caused by genetic, metabolic and inflammatory diseases as well as toxic agents and drug induced. A systematic US examination of the PTN will be performed for all patients. After Block administration at surgery day the block successes will be assessed and for the purposes of the present study, patients in whom the block was not successful will be excluded from further intervention and data analyses. Eight weeks after surgery, all study patients will return to hospital for repeat NCS and US.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital, University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic and non-diabetic patients undergoing foot surgery involving regional anesthesia/nerve blockade.

Description

Inclusion Criteria:

  • Patients undergoing PTN block for foot surgery
  • Type I diabetic patients (diagnosed more than 5 years), and II diabetic patients with demonstrated peripheral neuropathy
  • ASA I-III

Exclusion Criteria:

  • Non-diabetic neuropathy caused by genetic, metabolic and inflammatory diseases as well as toxic agents and drug induced (e.g. chemotherapy agents)
  • Psychiatric history
  • Allergy to local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetics with peripheral neuropathy
Patients with diabetes and peripheral neuropathy.
Procedure: Nerve conduction study and Ultrasound of the PTN
Nerve Conduction studies and ultrasound of PTN will be performed to the patient before the operation and 8 weeks postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Interval worsening of the severity of neuropathy
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
New functional neuropathy defined as any new sensory or motor deficit compared to preoperatively.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Sheila Riazi, MD, MSc, FRCPC, University Health Network - University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN 09-0803-AE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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