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The Investigators Are Comparing Lidocaine and Papaverine Nerve Blocks to Determine Which Improves Blood Flow Better, Making the Phoenix Sign Clearer on Imaging. This Helps Accurately Diagnose Nerve Compression, Improving Patient Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06919289
Enrollment
4
Registered
2025-04-09
Start date
2024-03-07
Completion date
2024-07-01
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drop Foot

Keywords

Nerve entrapment, Drop foot

Brief summary

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.

Detailed description

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

Interventions

DRUGInfiltration of papaverine

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.

Sponsors

US Neuropathy Centers
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* subjects were included if they were diabetic and neuropathic.

Exclusion criteria

* Patients with Trypanophobia

Design outcomes

Primary

MeasureTime frameDescription
Manual Motor Strength Testing of Anterior CompartmentFrom enrollment to 1 day of testingMovement 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 24, 2026