Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217267
• Other study ID #: SI140/2014
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2014
• Est. completion date: February 2018

Study information

• Verified date: November 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2018
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of medicine Siriraj Hospital Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Attal N, Rouaud J, Brasseur L, Chauvin M, Bouhassira D. Systemic lidocaine in pain due to peripheral nerve injury and predictors of response. Neurology. 2004 Jan 27;62(2):218-25. doi: 10.1212/01.wnl.0000103237.62009.77. — View Citation

Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003345. doi: 10.1002/14651858.CD003345.pub2. — View Citation

Kingery WS. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes. Pain. 1997 Nov;73(2):123-139. doi: 10.1016/S0304-3959(97)00049-3. — View Citation

Wallace MS, Dyck BJ, Rossi SS, Yaksh TL. Computer-controlled lidocaine infusion for the evaluation of neuropathic pain after peripheral nerve injury. Pain. 1996 Jul;66(1):69-77. doi: 10.1016/0304-3959(96)02980-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychological effects on depression, anxiety and stress	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.	at 3 month after serial lidocaine infusion
Primary	Pain intensity	Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable.	at 3 months after serial lidocaine infusion
Secondary	Quality of life using Utility score	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	at 3 month after serial lidocaine infusion

External Links

•   Department of Orthopaedic Siriraj Hospital
•   Siriraj Institutional Review Board
•   Siriraj Routine to Research