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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Hospital for Special Surgery, New York

Current Primary Outcome: Pain reduction [ Time Frame: 6 months post infusion ]

Evidence of changes in NRS pain scores between baseline and six months post infusion


Original Primary Outcome: Pain reduction [ Time Frame: 6 months post infusion ]

Evidence of changes in NRS pain scores between baseline and 6 months post infusion in patients receiving comprehensive ketamine infusion vs. placebo infusions.


Current Secondary Outcome:

  • Improved pain-related quality of life and mental status [ Time Frame: 6 months post infusion ]
    Compare pain-related quality of life and mental status data (including MMSE, SF-26v2, ORSDS, HADS, RASQ, WAQ, AROM, and threshold for touch) over six months.
  • Safety [ Time Frame: 6 months post infusion ]
    Verify the safety of dosing as defined in the protocol (e.g., adverse events, complications).


Original Secondary Outcome:

  • Improved pain-related quality of life and mental status [ Time Frame: 6 months post infusion ]
    Compare pain-related quality of life and mental status data over 6 months following subanesthetic ketamine infusions vs. control patients.
  • Safety [ Time Frame: 6 months post infusion ]
    Verify the safety of dosing as defined in the protocol.


Information By: Hospital for Special Surgery, New York

Dates:
Date Received: December 23, 2013
Date Started: April 2014
Date Completion: March 2016
Last Updated: March 21, 2017
Last Verified: March 2017