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

Stopped early · Phase 2

Conditions studied: Complex Regional Pain Syndrome

In brief

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

Key facts

Study ID

NCT02094352

Run by

Hospital for Special Surgery, New York

People needed

3

Starts

2014-03-24

Expected to finish

2015-04-20

Last updated by the study team

2018-01-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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