Diabetic PolyneuropathyNCT01488474
Peripheral Nerve Stimulation in Diabetic Patients
An observational study of Diabetic Polyneuropathy, run by Medical University of Graz at 1 site in Austria.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- peripheral nerve stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients scheduled for lower limb surgery and are eligible for a popliteal sciatic nerve block
Who may be able to join
- Patients of both sexes
- age more than 18 years
- American Society of Anesthesiology status 1 to 4
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- peripheral nerve stimulation
- Keywords
- regional anesthesia, peripheral nerve stimulation, diabetes, diabetic neuropathy
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral nerve stimulationProcedure or surgery
defining the minimal current threshold for distal motor response
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus (DM) | Patients with diagnosed diabetes mellitus type 1 or 2 undergoing surgery of the lower limb and are receiving regional anesthesia with peripheral nerve stimulation Receives: Procedure: peripheral nerve stimulation | |
| Control (C) | Patients with no history of diabetes mellitus Type 1 or 2 undergoing surgery of the lower limb and are receiving regional anesthesia with peripheral nerve stimulation Receives: Procedure: peripheral nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal current threshold for distal motor response at needle tip nerve contact
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rigaud Marcel, MD, Medical University of Graz
- Investigators
- Marcel Rigaud, PD, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488474
- Sponsor's protocol ID
- KLI 135
- Status last verified
- Jan 2015
- First submitted
- 2 Dec 2011
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heschl S, Hallmann B, Zilke T, Gemes G, Schoerghuber M, Auer-Grumbach M, Quehenberger F, Lirk P, Hogan Q, Rigaud M. Diabetic neuropathy increases stimulation threshold during popliteal sciatic nerve block. Br J Anaesth. 2016 Apr;116(4):538-45. doi: 10.1093/bja/aew027.
PubMed 26994231
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Diabetic Neuropathy on Current Settings During Peripheral Nerve Stimulation in Regional Anesthesia
- ClinicalTrials.gov ID
- NCT01488474
- Acronym / sponsor ID
- KLI 135
- Conditions
- Diabetic Polyneuropathy
- Keywords
- regional anesthesia, peripheral nerve stimulation, diabetes, diabetic neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus (DM) | – | Procedure: peripheral nerve stimulationPatients with diagnosed diabetes mellitus type 1 or 2 undergoing surgery of the lower limb and are receiving regional anesthesia with peripheral nerve stimulation |
| Control (C) | – | Procedure: peripheral nerve stimulationPatients with no history of diabetes mellitus Type 1 or 2 undergoing surgery of the lower limb and are receiving regional anesthesia with peripheral nerve stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients scheduled for lower limb surgery and are eligible for a popliteal sciatic nerve block
Key inclusion criteria (4 listed)
- Patients of both sexes
- age more than 18 years
- American Society of Anesthesiology status 1 to 4
- signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral nerve stimulationdefining the minimal current threshold for distal motor response | Procedure or surgery | Control (C), Diabetes Mellitus (DM) |
Primary outcome
Minimal current threshold for distal motor response at needle tip nerve contact
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Derived from this study: PubMed 26994231Heschl S, Hallmann B, Zilke T, Gemes G, Schoerghuber M, Auer-Grumbach M, Quehenberger F, Lirk P, Hogan Q, Rigaud M. Diabetic neuropathy increases stimulation threshold during popliteal sciatic nerve block. Br J Anaesth. 2016 Apr;116(4):538-45. doi: 10.1093/bja/aew027.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Rigaud, PD, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Polyneuropathy, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal current threshold for distal motor response at needle tip nerve contact (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01488474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015; AzTrials last refreshed its copy on 1 Nov 2026.