Diabetic NeuropathyNCT02076945
Characteristics of Popliteal Sciatic Nerve Block in Patients With and Without Diabetic Neuropathy
A study testing US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%) in people with Diabetic Neuropathy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Background Between 25 and 55% of diabetic patients develop neuropathy secondary to hyperglycemia. High resolution bedside ultrasound has been demonstrated to be a useful tool to detect the presence of neuropathy prior to block performance, by measuring the cross-sectional area of the posterior tibial nerve: a value… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Aug 2016
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients 18-85 years old
- patients scheduled to undergo foot surgery
Who cannot join
- patients with neuropathy caused by genetic, metabolic and inflammatory diseases, as well as toxic agents and drugs (eg chemotherapy agents);
- patients with chronic pain syndrome;
- patients with contraindications for regional anesthesia (e.g., allergy to local anesthetics);
- chronic consumption of opioids.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
CHUV (Centre Hospitalier Universitaire Vaudois)
Lausanne, Canton of Vaud, 1011
About this study
Background Between 25 and 55% of diabetic patients develop neuropathy secondary to hyperglycemia. High resolution bedside ultrasound has been demonstrated to be a useful tool to detect the presence of neuropathy prior to block performance, by measuring the cross-sectional area of the posterior tibial nerve: a value superior to 19.01 mm2 at a distance of 3 cm above the medial malleolus has an optimal threshold value for identification of diabetic sensorimotor polyneuropathy.
Animal data showed that duration of sciatic nerve block with local anesthetics is longer in diabetic rats compared with non-diabetic rats. Characteristics of a peripheral nerve blockade in humans with diabetic sensorimotor neuropathy are unknown.
Read more
Aim The aim of this study is to compare duration of analgesia and other characteristics of an ultrasound-guided popliteal sciatic nerve block between diabetic patients with neuropathy, diabetic patients without neuropathy and non-diabetic patients without neuropathy, based on the ultrasound-measured cross-sectional area of the posterior tibial nerve.
Hypothesis We hypothesize that diabetic patients with neuropathy will have a duration of analgesia lasting 50% longer than patients without neuropathy.
Methods This will be an observational study on diabetic and non-diabetic patients, with and without peripheral neuropathy, based on the ultrasound-measured cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus (cut-off value, 19.01 mm2)
All patients will receive ultrasound-guided sciatic nerve block with 30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%, with the needle tip positioned at the bifurcation of the sciatic nerve in peroneal and tibial nerve, below the common fascia or paraneurium. Block success will be confirmed by loss of sensation to pinprick in the distribution of the common peroneal and tibial nerves 30 minutes following local anesthetic injection. This procedure will be completed by a saphenous nerve block. Postoperative pain management will be standardized.
Pain and block-related endpoints will be collected such as onset time of action of sensory and motor blockades, duration of analgesia, pain scores and opiates consumption among others.
Relevance Defining the duration of analgesia in case of diabetic neuropathy will help regional anesthesiologists to better define the type and doses of drugs that will be injected and to better prescribe the postoperative multimodal analgesic treatment.
- Conditions
- Diabetic Neuropathy
- Being tested
- US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)
- Keywords
- Regional anesthesia, Diabetic neuropathy, Ultrasound
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Active comparator | Patients without diabetes and without peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus <19.01 mm2) Receives: Procedure: US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%) |
| Diabetic patients without neuropathy | Experimental | Patients with diabetes but without peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus <19.01 mm2) Receives: Procedure: US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%) |
| Diabetic patients with neuropathy | Experimental | Patients with diabetes and with peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus > 19.01 mm2) Receives: Procedure: US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Measured: with 24 hours after block performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076945
- Sponsor's protocol ID
- CHUV-40/14
- Status last verified
- Sep 2016
- First submitted
- 27 Feb 2014
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Popliteal Sciatic Nerve Block in Patients With and Without Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT02076945
- Acronym / sponsor ID
- CHUV-40/14
- Conditions
- Diabetic Neuropathy
- Keywords
- Regional anesthesia, Diabetic neuropathy, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Mar 2014 (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.
Background Between 25 and 55% of diabetic patients develop neuropathy secondary to hyperglycemia. High resolution bedside ultrasound has been demonstrated to be a useful tool to detect the presence of neuropathy prior to block performance, by measuring the cross-sectional area of the posterior tibial nerve: a value superior to 19.01 mm2 at a distance of 3 cm above the medial malleolus has an optimal threshold value for identification of diabetic sensorimotor polyneuropathy.
Animal data showed that duration of sciatic nerve block with local anesthetics is longer in diabetic rats compared with non-diabetic rats. Characteristics of a peripheral nerve blockade in humans with diabetic sensorimotor neuropathy are unknown.
Aim The aim of this study is to compare duration of analgesia and other characteristics of an ultrasound-guided popliteal sciatic nerve block between diabetic patients with neuropathy, diabetic patients without neuropathy and non-diabetic patients without neuropathy, based on the ultrasound-measured cross-sectional area of the posterior tibial nerve.
Hypothesis We hypothesize that diabetic patients with neuropathy will have a duration of analgesia lasting 50% longer than patients without neuropathy.
Methods This will be an observational study on diabetic and non-diabetic patients, with and without peripheral neuropathy, based on the ultrasound-measured cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus (cut-off value, 19.01 mm2)
All patients will receive ultrasound-guided sciatic nerve block with 30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%, with the needle tip positioned at the bifurcation of the sciatic nerve in peroneal and tibial nerve, below the common fascia or paraneurium. Block success will be confirmed by loss of sensation to pinprick in the distribution of the common peroneal and tibial nerves 30 minutes following local anesthetic injection. This procedure will be completed by a saphenous nerve block. Postoperative pain management will be standardized.
Pain and block-related endpoints will be collected such as onset time of action of sensory and motor blockades, duration of analgesia, pain scores and opiates consumption among others.
Relevance Defining the duration of analgesia in case of diabetic neuropathy will help regional anesthesiologists to better define the type and doses of drugs that will be injected and to better prescribe the postoperative multimodal analgesic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy patients | Active comparator | Procedure: US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)Patients without diabetes and without peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus <19.01 mm2) |
| Diabetic patients without neuropathy | Experimental | Procedure: US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)Patients with diabetes but without peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus <19.01 mm2) |
| Diabetic patients with neuropathy | Experimental | Procedure: US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)Patients with diabetes and with peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus > 19.01 mm2) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients 18-85 years old
- patients scheduled to undergo foot surgery
Key exclusion criteria (4 listed)
- patients with neuropathy caused by genetic, metabolic and inflammatory diseases, as well as toxic agents and drugs (eg chemotherapy agents);
- patients with chronic pain syndrome;
- patients with contraindications for regional anesthesia (e.g., allergy to local anesthetics);
- chronic consumption of opioids.
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 |
|---|---|---|
| US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%) | Procedure or surgery | Diabetic patients with neuropathy, Diabetic patients without neuropathy, Healthy patients |
Primary outcome
Duration of analgesia
Time frame: with 24 hours after block performance
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 27 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%) in people with Diabetic Neuropathy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 2 inclusion and 4 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 27 Sep 2016. 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 Switzerland. 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?
Duration of analgesia (time frame: with 24 hours after block performance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2016.