Indiana Foot and Ankle
Jasper, Indiana, 47546, United States
NCT Number: NCT06919289
This pilot study aims to investigate the effects of nerve blocks in patients with diabetic peripheral neuropathy through a double-blinded, randomized trial involving 4 patients. Each participant will receive bilateral peripheral nerve blocks using either lidocaine or papaverine. Following randomization, each patient will receive one medication in one leg and the alternate medication in the contralateral leg. Researchers will measure parameters including motor strength, sensory function (two-point discrimination), arterial blood flow via Doppler ultrasound, and microvascular perfusion using near-infrared spectroscopy both prior to and following nerve block administration. This research seeks to explore potential diagnostic and therapeutic applications for peripheral nerve entrapment, a common yet challenging clinical condition.
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Interventional
Not applicable
Jasper, Indiana, 47546, United States
Detailed Analysis of the Phoenix Sign and Vascular Changes Following Nerve Blocks in Diabetic Neuropathy
Study Background and Purpose
This study investigates the vascular and neurological phenomena associated with peripheral nerve blocks in patients with diabetic neuropathy. The primary aim is to assess whether observed changes following nerve block administration can be attributed to vasodilatory effects of lidocaine or neurological mechanisms.
Common peroneal nerve (CPN) entrapment is the third most common nerve entrapment pathology in humans and frequently results in foot drop, characterized by difficulty lifting the front part of the foot.
Study Design and Methodology
This pilot study is a double-blinded, randomized trial involving 4 diabetic patients presenting bilateral anterior compartment weakness affecting dorsiflexion. All participants will have confirmed diabetic neuropathy with severe sensory impairment.
Key methodological elements:
Randomized administration of 0.5 cc of papaverine HCL (30 mg/ml) or 0.5 cc of 1% lidocaine without epinephrine.
Initial randomization of the first leg via coin toss, with the contralateral leg receiving the alternate medication.
Double-blinded design, ensuring neither patients nor evaluating physicians are aware of medication allocation for each leg.
Ultrasound-guided perineural injection at the fibular neck level.
Comprehensive pre- and post-injection assessments.
Study assessments include:
Macrovascular assessment:
Ultrasound Doppler waveform analysis.
Measurement of blood flow velocity in dorsalis pedis and posterior tibial arteries.
Microvascular assessment:
Kent Snapshot Near-Infrared (NIR) imaging of dorsal and plantar foot surfaces.
Measurement of hemoglobin, deoxyhemoglobin, oxygen saturation (SpO2), and total hemoglobin.
Imaging scheduled pre-injection, at 4 minutes post-injection, and at 10 minutes post-injection.
Motor function assessment:
Movement Against Manual Resistance (MAMR) scored from 1-5 (normalized to 0.2-1.0).
Evaluation of three muscles: extensor hallucis longus (EHL), tibialis anterior (TA), and extensor digitorum longus (EDL).
Dynamometer measurements of EHL muscle strength (Newtons, N).
Sensory assessment:
Two-point discrimination testing
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study was randomized and double blinded. For randomization, the first extremity had either an infiltration of 0.5 cc of papaverine HCL (30mg/ml) for a 15mg perineural infiltration, or .5 cc of 1% lidocaine without epinephrine determined by a coin toss application.
The study was randomized and double blinded. For randomization, the first extremity had either an infiltration of 0.5 cc of papaverine HCL (30mg/ml) for a 15mg perineural infiltration, or .5 cc of 1% lidocaine without epinephrine determined by a coin toss application.
Time frame: From enrollment to 1 day of testing
Movement Against Manual Resistance (MAMR) was evaluated using a scale of 1-5 out of 5. This was normalized so that 1/5 = 0.2, and 5/5=1.0. This was performed on three muscles of the anterior compartment, extensor hallusis longus (EHL), tibialis anterior (TA), and extensor digitorum longus (EDL) and the result for three muscles were averaged. In addition, the EHL was evaluated with a dynamometer, in Newtons (N) separately.
US Neuropathy Centers
Other
Quantifying the Phoenix Sign: A Comparative, Randomized Control Trial Analysis of Lidocaine and Papaverine-Induced Vascular Enhancement After Common Peroneal (Fibular) Nerve Blocks for the Diagnosis of a Focal Peripheral Nerve Entrapment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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