Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome

• Status: Terminated
• Trial end date: 2015-04-20
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Ketamine

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