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Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT02217267
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Drug: Lidocaine Drug: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain : A Pilot Study
Study Start Date : August 1, 2014
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo group
Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times
Drug: Placebo
Active Comparator: Lidocaine group
Lidocaine 3mg/kg in Normal Saline to 50 ml intravenous infusion in 1 hour once a week 4 times
Drug: Lidocaine
Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour
Other Name: Intravenous lidocaine




Primary Outcome Measures :
  1. Pain score [ Time Frame: at 3 months after serial lidocaine infusion ]
    By Verbal numerical scales


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: at 3 month after serial lidocaine infusion ]
    by EuroQol questionnaire


Other Outcome Measures:
  1. Emotion [ Time Frame: at 3 month after serial lidocaine infusion ]
    By Depression Anxiety Stress Scale 21 questionnaire



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217267


Locations
Thailand
Faculty of medicine Siriraj Hospital Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Suratsawadee Wangnamthip, M.D. Mahidol University

Additional Information:
Publications of Results:
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02217267     History of Changes
Other Study ID Numbers: SI140/2014
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Mahidol University:
Peripheral neuropathy

Additional relevant MeSH terms:
Neuralgia
Peripheral Nervous System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action