Characteristics of Popliteal Sciatic Nerve Block in Patients With and Without Diabetic Neuropathy

NCT02076945 | Completed

• 1 other identifier: CHUV-40/14
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetic Neuropathy

Keywords

Regional anesthesia; Diabetic neuropathy; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  with 24 hours after block performance

Study Arms (3)

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)

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)

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)

Procedure: US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)

Interventions

US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%) PROCEDURE

Diabetic patients with neuropathy; Diabetic patients without neuropathy; Healthy patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients 18-85 years old
• patients scheduled to undergo foot surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

CHUV (Centre Hospitalier Universitaire Vaudois)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; program director, regional aneshesia

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 4, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

CH (1)