Can Ultrasound Predict Nerve Injury Following Posterior Tibial Nerve Block in Patients With Peripheral Neuropathy?
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|ClinicalTrials.gov Identifier: NCT01002053|
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : November 24, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|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|
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.
- Interval worsening of the severity of neuropathy [ Time Frame: 8 weeks ]
- New functional neuropathy defined as any new sensory or motor deficit compared to preoperatively. [ Time Frame: 8 weeks ]
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 ClinicalTrials.gov identifier (NCT number): NCT01002053
|Toronto Western Hospital, University Health Network|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Sheila Riazi, MD, MSc, FRCPC||University Health Network - University of Toronto|