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

Phase 2

Terminated

• Conditions: Complex Regional Pain Syndrome
• Interventions: Drug: Ketamine Infusion + Epidural Infusion; Drug: Control Group + Epidural infusion; Drug: Ketamine Booster Infusion; Drug: Control Group Booster Infusion

• Registration Number: NCT02094352
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Study Timeline

• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Study Start: 2014-03-24
• Primary Completion: 2015-04-20
• Study Completion: 2015-04-20
• Results First Submitted: 2017-03-21
• Results First Submitted QC: 2017-05-18
• Results First Posted: 2017-06-14
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Infusion + Epidural Infusion + Booster Infusion	Ketamine 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.
Ketamine Infusion + Epidural Infusion + Booster Infusion	Ketamine Infusion + Epidural 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.
Control Group + Epidural Infusion + Booster Infusion	Control Group 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.
Control Group + Epidural Infusion + Booster Infusion	Control Group + Epidural 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.

Primary Outcome Measures

Name	Time	Method
Pain Reduction	6 months post infusion	Evidence of changes in NRS pain scores between baseline and six months post infusion

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States