Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

NCT ID: NCT02217267

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2018-02-28

Brief Summary

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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

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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).

Conditions

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Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Lidocaine group

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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

Interventions

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Lidocaine

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Intravenous lidocaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suratsawadee Wangnamthip, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of medicine Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 16235318 (View on PubMed)

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.

Reference Type RESULT
PMID: 14745057 (View on PubMed)

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.

Reference Type RESULT
PMID: 9415498 (View on PubMed)

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.

Reference Type RESULT
PMID: 8857633 (View on PubMed)

Related Links

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http://www.si.mahidol.ac.th/th/division/sirb/

Siriraj Institutional Review Board

Other Identifiers

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SI140/2014

Identifier Type: -

Identifier Source: org_study_id

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