Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Ketamine Infusion + Epidural Infusion
- Conditions
- Complex Regional Pain Syndrome
- Sponsor
- Hospital for Special Surgery, New York
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Pain Reduction
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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: 1. Receives epidural infusion 2. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ketamine Infusion + Epidural Infusion + Booster Infusion
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.
Intervention: Ketamine Infusion + Epidural Infusion
Ketamine Infusion + Epidural Infusion + Booster Infusion
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.
Intervention: Ketamine Booster Infusion
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.
Intervention: Control Group + Epidural infusion
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.
Intervention: Control Group Booster Infusion
Outcomes
Primary Outcomes
Pain Reduction
Time Frame: 6 months post infusion
Evidence of changes in NRS pain scores between baseline and six months post infusion