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

NCT06919289 | Completed

• 2 other identifiers: JIN-2025-0326USNC-2025-3
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Drop Foot

Keywords

Nerve entrapment; Drop foot

Outcome Measures

Primary Outcomes (1)

• Manual Motor Strength Testing of Anterior Compartment

  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.

  From enrollment to 1 day of testing

Study Arms (2)

Lidocaine group

ACTIVE COMPARATOR

This arm is randomized to the laterality of the subject for either lidocaine or papaverine

Drug: Lidocaine infiltration

Papavarine

ACTIVE COMPARATOR

This arm is randomized to the laterality of the subject for either lidocaine or papaverine, for the first infiltration. The contralateral extremity will then receive the agent that was not administered on the first side from randomization.

Drug: Infiltration of papaverine

Interventions

Infiltration of papaverine DRUG

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.

Papavarine

Lidocaine infiltration DRUG

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.

Lidocaine group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects were included if they were diabetic and neuropathic.

You may not qualify if:

• Patients with Trypanophobia

Sponsors & Collaborators

• US Neuropathy Centers: lead

Study Sites (1)

Indiana Foot and Ankle

Jasper, Indiana, 47546, United States

Location

Related Publications (1)

• Barrett SL, Boyd B, DuCasse S, Nassier W, Mitchell N, Nagra AP, Dalmau-Pastor M, Yamasaki DS, Nickerson S. Is the phoenix sign phenomenon due to vasodilation? A double-blinded, randomized controlled trial comparing motor function recovery after diagnostic common fibular nerve block with lidocaine and papaverine. BMC Musculoskelet Disord. 2024 Oct 23;25(1):840. doi: 10.1186/s12891-024-07972-3.

  PMID: 39443927 BACKGROUND

MeSH Terms

Conditions

Peroneal Neuropathies; Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: US Neuropathy Centers Medical Director

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 9, 2025
• Study Start: March 7, 2024
• Primary Completion: March 7, 2024
• Study Completion: July 1, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)