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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01002053
First received: October 26, 2009
Last updated: April 25, 2012
Last verified: November 2011
  Purpose

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 Intervention
Diabetic Neuropathy
Procedure: Nerve conduction study and Ultrasound of the PTN

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Can Ultrasound Predict Nerve Injury Following Posterior Tibial Nerve Block in Patients With Peripheral Neuropathy?

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Interval worsening of the severity of neuropathy [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002053

Contacts
Contact: Kris Abbas, M.D (416) 603 -5800 ext 6237 kris.abbas@uhn.ca

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

Publications:

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01002053     History of Changes
Other Study ID Numbers: UHN 09-0803-AE
Study First Received: October 26, 2009
Last Updated: April 25, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
diabetes
neuropathy
ankle block
regional anesthesia
ultrasound
nerve localization
Nerve localization in patients undergoing foot surgery and having ankle block

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on November 25, 2014