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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01002053
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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.

Condition or disease Intervention/treatment
Diabetic Neuropathy Procedure: Nerve conduction study and Ultrasound of the PTN

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Can Ultrasound Predict Nerve Injury Following Posterior Tibial Nerve Block in Patients With Peripheral Neuropathy?
Study Start Date : February 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Interval worsening of the severity of neuropathy [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. New functional neuropathy defined as any new sensory or motor deficit compared to preoperatively. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic and non-diabetic patients undergoing foot surgery involving regional anesthesia/nerve blockade.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01002053

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Canada, Ontario
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Sheila Riazi, MD, MSc, FRCPC University Health Network - University of Toronto

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Responsible Party: University Health Network, Toronto Identifier: NCT01002053    
Other Study ID Numbers: UHN 09-0803-AE
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2011
Keywords provided by University Health Network, Toronto:
ankle block
regional anesthesia
nerve localization
Nerve localization in patients undergoing foot surgery and having ankle block
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases