Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Lidocaine infusion; Saline infusion
Intervention description: 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; A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain, Opioid dependence, Lidocaine infusion

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.
    

Eligibility 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).