Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

Phase 3

Completed

• Conditions: Peripheral Neuropathy
• Interventions: Drug: Placebo; Drug: Lidocaine

• Registration Number: NCT02217267
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study Start: 2014-08-01
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-15
• Primary Completion: 2017-12-29
• Study Completion: 2018-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times
Lidocaine group	Lidocaine	Lidocaine 3mg/kg in Normal Saline to 50 ml intravenous infusion in 1 hour once a week 4 times

Primary Outcome Measures

Name	Time	Method
Pain intensity	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 Outcome Measures

Name	Time	Method
Quality of life using Utility score	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

Trial Locations

Locations (1)

Faculty of medicine Siriraj Hospital Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand