Clinical trial NCT02217267: Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain
Official title: Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain : A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Neuropathy
Keywords: Peripheral neuropathy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: at 3 months after serial lidocaine infusion
Secondary outcomes:
measure: Quality of life using Utility score
timeFrame: at 3 month after serial lidocaine infusion
Other outcomes:
measure: Psychological effects on depression, anxiety and stress
timeFrame: at 3 month after serial lidocaine infusion
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of medicine Siriraj Hospital Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Suratsawadee Wangnamthip, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.