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

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

Detailed Description
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Potential patients must clear all study requirements to be enrolled. Study requirements include labwork, psychiatric evaluation, and cardiology evaluation. Once enrolled, patients will be in one of two groups: Receives epidural infusion Receives epidural and ketamine infusions The patient and study staff are blinded. This study requires multiple visits to Hospital for Special Surgery in New York City over the course of three months and concludes with a final visit after six months. The study will only cover costs associated with the scheduled in-patient and out-patient visits. The study patient will be responsible for all other costs (including travel and hotel accommodations) that he/she may incur for participating in this study.

Official Title
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Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome

Conditions
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Complex Regional Pain Syndrome

Intervention / Treatment
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* Drug: Ketamine Infusion + Epidural Infusion
* Drug: Control Group + Epidural infusion
* Drug: Ketamine Booster Infusion
* Drug: Control Group Booster Infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine Infusion + Epidural Infusion + Booster Infusion<br>Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three ketamine booster infusions over the course of three months. | Drug: Ketamine Infusion + Epidural Infusion<br>* The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.<br>* Other names: Epidural;Drug: Ketamine Booster Infusion<br>* Patients will receive three ketamine booster infusions over the course of three months.<br>* Other names: Ketamine;|
| Placebo Comparator: Control Group + Epidural Infusion + Booster Infusion<br>Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three saline booster infusions over the course of three months. | Drug: Control Group + Epidural infusion<br>* The saline and epidural infusions will be administered over 96 hours with appropriate titration.<br>* Other names: Epidural;Drug: Control Group Booster Infusion<br>* Patients will receive three saline booster infusions over the course of three months.<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | Evidence of changes in NRS pain scores between baseline and six months post infusion | 6 months post infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complex Regional Pain Syndrome, Pain management, Ketamine infusion