NCT06637046

Does Blood Vessel Vasodilation, Caused by Focal Infiltration of Lidocaine Cause Temporary Nerve Functional Recovery for Patients with Common Peroneal Nerve Injury or Entrapment: Testing the 'Phoenix Sign' Effect Between Lidocaine (a Common Local Anesthetic) and Papaverine, a Know Vasodilator

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Stephen Barrett · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare lidocaine without epinephrine to papaverine a known vasodilatory agent, in creating improved motor strength in patients with drop foot involving an entrapment of the Common Peroneal Nerve. This phenomenon has been named the Phoenix Sign and is a very specific peripheral nerve block. Researchers will compare the effects of the above agent for pre and post infiltration changes in motor strength. Participants will: * Will be randomized to one of either agents already listed * After receiving the ultrasound guided injection, motor testing will be evaluated in 4-6 minutes with manual motor strength testing of the anterior compartment muscles. * No additional follow will be required

Detailed description

A double-blinded, randomised, prospective controlled trial was conducted at US Neuropathy Centers in Marietta, GA, under the approval of the Kennesaw State University Institutional Review Board. Patients with weak dorsiflexion of the ankle or a drop foot were recruited from the existing clinical practice at US Neuropathy Centers. Cohort inclusion criteria also included a stable medical and medication status, ages 18-85, speaking English as the primary language, and ambulatory. Walking aids or ankle-foot orthosis were permitted.. Based on the inclusion criteria, only 20 patients were enrolled. Patients were recruited over a period of 1 year and two months from January 2021 to March 2022 with no requirement for follow-up. The enrolment phase was concluded as the study was originally designed as a pilot investigation, with recruitment limited to a single, small medical practice. A total of 20 patients were successfully enrolled within this setting.Participants were randomised by the throw of dice to injection of 0.3 cc of Papaverine HCl 10 mg/mL or 0.3 cc of 1% Lidocaine HCl adjacent to CFN in a room separate from patient room. Injection solutions were prepared by non-blinded assistants and were visually indistinguishable. Patients and physicians are blinded to drugs received. Motor strength of the Extensor Hallucis Longus (EHL), Tibialis Anterior (TA), and Extensor Digitorum Longus (EDL) muscles were tested. Strength was rated according to the Medical Research Council Manual Muscle Testing scale 0-5. The CFN at the fibular neck was identified under high-resolution ultrasound imaging. The injection site was prepared with alcohol, and ethyl chloride was used to anaesthetise the skin. A 30-gauge 1-inch needle was inserted adjacent to, but not within, the CFN. The infiltrate was delivered at the level of the fibular neck just proximal to where the CPN coursed beneath the deep fascia of the peroneus longus. This was immediately adjacent to the first known anatomical site of compression of the CPN. 0.3cc of the drug was delivered. The investigator then waited approximately five minutes and re-tested motor strength of the Extensor Hallucis Longus (EHL), Tibialis Anterior (TA), and Extensor Digitorum Longus (EDL) muscles manually.

Conditions

• Drop Foot

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic procedures	A 30-gauge 1-inch needle was inserted adjacent to, but not within, the CFN. The infiltrate was delivered at the level of the fibular neck just proximal to where the CPN coursed beneath the deep fascia of the peroneus longus. This was immediately adjacent to the first known anatomical site of compression of the CPN. 0.3cc of the drug was delivered.
DIAGNOSTIC_TEST	Lidocaine HCl	This study compares the vasodilatory effects of lidocaine to papaverine after diagnostic infiltration of the Common Peroneal Nerve in patients with demonstrated motor weakness of the EHL (extensor hallucis longus).

Timeline

• Start date: 2020-03-15
• Primary completion: 2022-02-15
• Completion: 2023-11-01
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: United States