Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Peripheral Neuropathy

Treatments: Drug: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02217267

SI140/2014

Details and patient eligibility

About

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

Full 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).

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

29 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times

Treatment:

Drug: Placebo

Lidocaine group

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine