NCT02217267

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

3.4 years

First QC Date

August 13, 2014

Last Update Submit

November 24, 2022

Conditions

Peripheral Neuropathy

Keywords

Peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of life using Utility score

    at 3 month after serial lidocaine infusion

Other Outcomes (1)

  • Psychological effects on depression, anxiety and stress

    at 3 month after serial lidocaine infusion

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Lidocaine group

ACTIVE COMPARATOR

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

Drug: Lidocaine

Interventions

LidocaineDRUG

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

Also known as: Intravenous lidocaine
Lidocaine group
PlaceboDRUG
Placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peripheral neuropathic pain from peripheral nerve injury within 6 months after injury
  • Well understand to Thai language in writing or listening

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 16235318RESULT

  • 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.

    PMID: 14745057RESULT

  • 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.

    PMID: 9415498RESULT

  • 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.

    PMID: 8857633RESULT

Related Links

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Suratsawadee Wangnamthip, M.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

August 1, 2014

Primary Completion

December 29, 2017

Study Completion

February 1, 2018

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

TH(1)