Peripheral Nerve Stimulation in Diabetic Patients

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Diabetic Polyneuropathy
Procedure: peripheral nerve stimulation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Influence of Diabetic Neuropathy on Current Settings During Peripheral Nerve Stimulation in Regional Anesthesia

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Minimal current threshold for distal motor response at needle tip nerve contact [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
  • blood samples
  • any material from surgical resections

Estimated Enrollment: 140
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diabetes Mellitus (DM)
Patients with diagnosed diabetes mellitus type 1 or 2
Procedure: peripheral nerve stimulation
defining the minimal current threshold for distal motor response
Control (C)
Patients with no history of diabetes mellitus Type 1 or 2
Procedure: peripheral nerve stimulation
defining the minimal current threshold for distal motor response

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  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: NCT01488474

Contacts
Contact: Marcel Rigaud, MD, PD +43 316 385 ext 14663 marcel.rigaud@medunigraz.at

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Marcel Rigaud, MD    +43 316 385 ext 14663    marcel.rigaud@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Marcel Rigaud, PD, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Rigaud Marcel, MD, Principal Investigator, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01488474     History of Changes
Other Study ID Numbers: KLI 135
Study First Received: December 2, 2011
Last Updated: May 4, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
regional anesthesia
peripheral nerve stimulation
diabetes
diabetic neuropathy

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

ClinicalTrials.gov processed this record on August 21, 2014