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Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219321
Recruitment Status : Terminated (Lack of Funding)
First Posted : August 18, 2014
Results First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Enas Kandil, University of Texas Southwestern Medical Center

Brief Summary:

Prescription drug abuse represents a major healthcare problem, with treatment costs reaching billions of dollars annually in the United States alone. Today opioids are commonly prescribed for chronic non-cancer pain and are only partially effective for short-term pain relief. Whereas opioids are initially part of the solution for pain, it eventually often turns to be a problem in patient with chronic pain. Long-term treatment with opioids can be complicated by development of tolerance, dependency, addiction, abnormal pain sensitivity, hormonal changes, and immune modulation. Unfortunately, the chronic use of anti-inflammatory drugs is associated with a marked increase in adverse effects.

The purpose of this study is to determine whether systemic administration of lidocaine provides effective pain relief in opioid dependent chronic pain patients. Investigators intend to demonstrate that lidocaine infusion can improve pain relief and physical function in opioid dependent patients, thus improving compliance and patient satisfaction, which may potentially help wean patients off narcotics. The long-term goal of this proposal is to decrease opioid dependence in chronic pain patients by using lidocaine infusion.


Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Lidocaine infusion Drug: Saline infusion Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients
Actual Study Start Date : December 2014
Actual Primary Completion Date : May 14, 2015
Actual Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Lidocaine infusion
A continuous intravenous infusion of lidocaine
Drug: Lidocaine infusion
Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours
Other Name: Intravenous lidocaine

Placebo Comparator: Saline infusion
A continuous intravenous infusion of saline
Drug: Saline infusion
A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours
Other Name: Isotonic Sodium Chloride




Primary Outcome Measures :
  1. Intensity of Pain [ Time Frame: Immediately after continuous 4-hours Intravenous lidocaine infusion ]
    Visual Analog Pain Scores on a scale of 0 to 10 (0=no pain and 10=worst pain)


Secondary Outcome Measures :
  1. Withdrawal Time (Seconds) [ Time Frame: Immediately after Lidocaine Infusion ]
    The time to withdraw at the Cold Pressor Task immediately after 4-hours intravenous continuous lidocaine infusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years old -Patient currently on stable dose of opioids for more than six months period -
  • Patients with Chronic uncontrolled neuropathic pain with documented pain score > or = 4 despite opioids
  • Not currently abusing opioids or other illicit drugs as demonstrated by history and negative urine toxicology screen
  • Patient agrees to come to all follow up visits at 1, 2, and 3 week following infusion
  • Having baseline/screening EKG

Exclusion Criteria:

  • Individuals meeting DSM-V dependence criteria for alcohol, benzodiazepine, CNS stimulant, marijuana or other drug of abuse.
  • Hepatic dysfunction as determined by history and physical or clinical significant lab.
  • Cardiac arrhythmias including heart block and QT prolongation as determined by history or baseline EKG.
  • Subject has inability to understand and cooperate with study procedures or provide informed consent.
  • Subject has history of intolerance or allergic reaction to lidocaine.
  • Subject has history of seizures.
  • Raynaud's disease
  • Renal impairment as determined by clinically significant labs.
  • Women of childbearing age who either have:

    1. A positive pregnancy test
    2. Unprotected heterosexual sex since their previous menses or;
    3. Not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill).

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): NCT02219321


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9068
Parkland Health Hospital System
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Enas Kandil, MD University of Texas Southwestern Medical Center
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Responsible Party: Enas Kandil, Asistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02219321    
Other Study ID Numbers: 062014-002
First Posted: August 18, 2014    Key Record Dates
Results First Posted: March 25, 2020
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Enas Kandil, University of Texas Southwestern Medical Center:
Pain, Opioid dependence, Lidocaine infusion
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
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