NCT02094352

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Complex Regional Pain Syndrome

Interventions

Type	Name	Description
DRUG	Ketamine Infusion + Epidural Infusion	The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
DRUG	Control Group + Epidural infusion	The saline and epidural infusions will be administered over 96 hours with appropriate titration.
DRUG	Ketamine Booster Infusion	Patients will receive three ketamine booster infusions over the course of three months.
DRUG	Control Group Booster Infusion	Patients will receive three saline booster infusions over the course of three months.

Timeline

• Start date: 2014-03-24
• Primary completion: 2015-04-20
• Completion: 2015-04-20
• First posted: 2014-03-21
• Last updated: 2018-01-31
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States