Peripheral Nerve Stimulation in Diabetic Patients

This study is currently recruiting participants.
Verified May 2013 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Rigaud Marcel, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01488474
First received: December 2, 2011
Last updated: May 4, 2013
Last verified: May 2013

December 2, 2011
May 4, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
Minimal current threshold for distal motor response at needle tip nerve contact [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01488474 on ClinicalTrials.gov Archive Site
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Peripheral Nerve Stimulation in Diabetic Patients
Influence of Diabetic Neuropathy on Current Settings During Peripheral Nerve Stimulation in Regional Anesthesia

The prevalence of diabetes mellitus (DM) in industrialized countries is estimated to be about 7.3% and its incidence has been growing in recent years. The prevalence of diabetic neuropathy in the diabetic patient population is up to 50%. When limb surgery is necessary, it is reasonable to assume that diabetic patients will benefit from a peripheral regional anesthesia because of the severe comorbidities associated with DM. On the other hand, the use of regional anesthesia (RA) has generally not been recommended in patients with preexisting neuropathies mainly because of medical liability issues, as worsening neuropathy could be attributed to nerve damage caused by the regional anesthetic. The current state of the art of peripheral regional anesthesia for the identification of correct placement of an injection needle suitably close to the target nerve is to elicit a motor response by current injection through the needle. Constant reduction of the current as the nerve is approached ensures close proximity so that an effective nerve block is obtained when the local anesthetic is delivered through the needle, and absence of a motor response at 0.3 mA is generally accepted as a safety marker to avoid harmful intraneural injection. An important deficit in our understanding is whether diabetic neuropathy influences the stimulation parameters for peripheral nerve stimulation (PNS), possibly decreasing safety.

The currently proposed research is guided by the hypothesis that nerves in patients with DM are more resistant to stimulation and the current thresholds for PNS have to be set much higher to prevent injections from occurring within the epineurium. The investigators will examine the effect of DM on nerve excitability in a blinded, prospective, observational case control trial. Accordingly, the investigators have defined following aims:

Specific Aim 1: To characterize the required stimulation current in patients with and without diabetes mellitus.

Specific Aim 2: Follow-up to examine if the rate of adverse neurologic events is higher in diabetic patients.

Specific Aim 3: Guided by the results, formulate recommendations for the performance of regional anesthesia in patients with a history of DM.

These experiments will provide better understanding of the needle-current-nerve relationship during peripheral nerve stimulation. Findings from this study will have a major impact on patient safety, especially in the subgroup with preexisting neuropathy, undergoing regional anesthesia.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
  • blood samples
  • any material from surgical resections
Probability Sample

Surgical patients scheduled for lower limb surgery and are eligible for a popliteal sciatic nerve block

Diabetic Polyneuropathy
Procedure: peripheral nerve stimulation
defining the minimal current threshold for distal motor response
  • Diabetes Mellitus (DM)
    Patients with diagnosed diabetes mellitus type 1 or 2
    Intervention: Procedure: peripheral nerve stimulation
  • Control (C)
    Patients with no history of diabetes mellitus Type 1 or 2
    Intervention: Procedure: peripheral nerve stimulation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients of both sexes
  • age more than 18 years
  • American Society of Anesthesiology status 1 to 4
  • signed informed consent

Exclusion Criteria:

  • Pregnancy
  • Allergies to local anesthetics
  • Unwillingness or incapability to sign informed consent
  • Any preexisting neurological deficit of the lower limb that cannot be attributed to diabetic neuropathy
  • Ongoing dual anti-platelet therapy
Both
18 Years and older
No
Contact: Marcel Rigaud, MD, PD +43 316 385 ext 14663 marcel.rigaud@medunigraz.at
Austria
 
NCT01488474
KLI 135
No
Rigaud Marcel, MD, Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Marcel Rigaud, PD, MD Medical University of Graz
Medical University of Graz
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP