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Completed

NCT Number: NCT02217267

Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6 months) at 3 months after first time of infusion

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Key information

Conditions

Peripheral Neuropathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of medicine Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

About this study

Peripheral nerve injury may give rise to severe and long-lasting types of pains which are often resistant to treatment such as opioid, tricyclic antidepressant or anticonvulsant. Lidocaine infusion has been the one of intractable neuropathic pain treatment . My hypothesis the serial lidocaine infusion can adequate pain control and can prevent chronic pain (central sensitisation). Therefore, we designed this prospective, randomised, double-blind, controlled study to evaluate the efficacy of serial lidocaine infusion in peripheral neuropathic pain compared with placebo in long term outcome (at 3 month).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Peripheral neuropathic pain from peripheral nerve injury within 6 months after injury
  • Well understand to Thai language in writing or listening

Exclusion criteria

  • Underlying Heart disease or Arrhythmia
  • Allergy to lidocaine, Gabapentin, Carbamazepine, tramadol
  • History of epilepsy
  • History of lidocaine used
  • Underlying Psychiatric disease
  • History of drug abuse
  • Pregnancy and nursing

Treatment and study plan

Lidocaine

Drug

Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour

Other names: Intravenous lidocaine

Placebo

Drug

Primary outcomes

  1. Pain intensity

    Time frame: at 3 months after serial lidocaine infusion

    Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable.

Secondary outcomes

  1. Quality of life using Utility score

    Time frame: at 3 month after serial lidocaine infusion

    Quality of life will be assessed using EuroQol5D5L and reported as a utility score (0-1.0) "0" represents death, and "0.1" means full health

Other outcomes

  1. Psychological effects on depression, anxiety and stress

    Time frame: at 3 month after serial lidocaine infusion

    The psychological effect will be assessed using DASS21. Each of these domains is assessed with a separate 7-item scale. Responses to the items are summed to create scales with a total possible score of 21 points, then multiplied by two to calculate the final score. The final score can then be graded in each domain: Normal (0-4), Mild (5-6), Moderate (7-11), Severe (11-13), and Extremely Severe (14+) for depression; Normal (0-3), Mild (4-5), Moderate (6-7), Severe (8-9) and Extremely Severe (10+) for anxiety; and Normal (0-7), Mild (8-9), Moderate (10-12), Severe (13-16) and Extremely Severe (14+) for stress.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain : A Pilot Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Aug 15, 2014
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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