Neuromas as the Cause of Pain

Overview

Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be relieved by injection of local anesthetics near painful neuromas in subjects with peripheral nerve injury.

Full Title of Study: “Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2018

Interventions

  • Drug: Lidocaine
  • Drug: Isotonic Saline

Arms, Groups and Cohorts

  • Active Comparator: Lidocaine
    • Lidocaine 2 ml injection with 2% Adrenaline
  • Placebo Comparator: Isotonic Saline
    • Isotonic Saline 2 ml Injection

Clinical Trial Outcome Measures

Primary Measures

  • Spontaneous pain on numerical rating scale (NRS 0-10)
    • Time Frame: 15 minutes after injection
    • The participant will be asked about spontaneous pain
  • Evoked pain on numerical rating scale (NRS 0-10)
    • Time Frame: 15 minutes after injection

Secondary Measures

  • Brush allodynia
    • Time Frame: 15 minutes after injection
    • Assesment of area (cm^2) using a SOMEDIC brush
  • Pinprick hyperalgesia
    • Time Frame: 15 minutes after injection
    • Assesment of area (cm^2) using a von Frey filament (60 g)
  • Cold allodynia
    • Time Frame: 15 minutes after injection
    • Assesment of area (cm^2) using a roll (20 degrees celcius)
  • Heat allodynia
    • Time Frame: 15 minutes after injection
    • Assesment of area (cm^2) using a roll (40 degrees celcius)

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects with peripheral nerve injury 3 months prior to participation Exclusion Criteria:

  • Severe somatic or psychiatric diseases – Other peripheral neuropathy – Lack of ability to cooperate to the clinical examination – Allergy to Lidocaine or similar analgetics

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danish Pain Research Center
  • Collaborator
    • Aarhus University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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