Please read the study inclusion & exclusion criteria shown below carefully prior to contacting the clinical trial organizers.
Descriptive Information
Brief Title ICMJE
Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome
Official Title ICMJE
Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome
Brief 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).
Detailed Description
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.
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.
Interventions:
Drug: Ketamine Infusion + Epidural Infusion
Drug: Ketamine Booster Infusion
Placebo Comparator: Control Group + Epidural Infusion + Booster Infusion
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.
Interventions:
Drug: Control Group + Epidural infusion
Drug: Control Group Booster Infusion
Recruitment Information
Recruitment Status ICMJE
Recruiting
Estimated Enrollment ICMJE
60
Completion Date
Not Provided
Estimated Primary Completion Date
December 2017 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE
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
I have had this for 20 years.I have been treated by Dr O’Malley and Dr Richman. I have been looking at the ketamine for a few months now. I had to stop treatment with Dr Richman for financial reasons. Please consider me. I can be reached at . Thank you
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