Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome
Condition: Complex Regional Pain Syndrome
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders
Intervention: Ketamine Infusion + Epidural Infusion; Control Group + Epidural infusion; Ketamine Booster Infusion; Control Group Booster Infusion
Intervention description: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.; The saline and epidural infusions will be administered over 96 hours with appropriate titration.; Patients will receive three ketamine booster infusions over the course of three months.; Patients will receive three saline booster infusions over the course of three months.
Intervention MeSH terms: Ketamine
Phase: Phase 2
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: Accepts Healthy Volunteers
Keywords: Complex Regional Pain Syndrome; Pain management; Ketamine infusion

Summary:

      The purpose of this study is to determine whether epidural and ketamine infusions are
      effective in the treatment of Complex Regional Pain Syndrome (CRPS).
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Patients must meet the Budapest CRPS criteria, including two or more symptom
             categories and three or more sign categories (as previously documented by a pain
             management physician or neurologist, or as observed on initial neurologic examination
             by the study investigator)

          -  Patients must have trialed at least three of the following therapies without relief
             judged adequate by the patient:

          -  Anti-depressants

          -  Anti-seizure medication

          -  Muscle relaxants

          -  Nerve blocks (somatic or sympathetic)

          -  Non-opioid analgesics

          -  Non-steroidal anti-inflammatory drugs

          -  Opioid analgesics

          -  Physical therapy

          -  Spinal cord stimulator trial

          -  Patients of either gender between the ages of 18 and 65 inclusive

          -  Patient report of a NRS pain score of at least 5 in at least two out-patient pain
             management physician clinic visits

        EXCLUSION CRITERIA:

          -  Patients younger than 18 or older than 65

          -  Patients who:

          -  Are pregnant

          -  Are affected with glaucoma

          -  Are affected with thyrotoxicosis

          -  Are lactating

          -  Are on chronic anticoagulation therapy

          -  Have autonomic dysfunction with hemodynamic instability

          -  Have cardiac rhythm disturbance

          -  Have cerebrovascular disease

          -  Have conditions that would preclude central line placement

          -  Have conditions that would preclude epidural catheter placement

          -  Have congestive heart failure

          -  Have coronary artery disease

          -  Have creatinine level above 1.5

          -  Have electrolyte disturbance

          -  Have had previous reaction to IV contrast dye

          -  Have history of deep vein thrombosis

          -  Have history of systemic administration of ketamine for the treatment of pain

          -  Have liver disease

          -  Have known history of psychosis, significant thought disorder, or untreated (bipolar
             disorder depression or anxiety disorder ok)

          -  Have uncontrolled hypertension

          -  Any patient who is unable to provide consent due to cognitive difficulties

          -  Non-English speakers, as some of the instruments are only validated in English

          -  Patients with active litigation or workers compensation related to CRPS

          -  Patients with an intolerance or allergy to any medication planned as a component of
             the study

          -  Patients with known history of illegal drug use or alcohol dependence