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

January 8, 2018 updated by: Hospital for Special Surgery, New York

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

The purpose of this study is to determine whether epidural and ketamine infusions are effective in the treatment of Complex Regional Pain Syndrome (CRPS).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ketamine Infusion + Epidural Infusion
The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
Other Names:
  • Ketamine
  • Epidural
Drug: Ketamine Booster Infusion
Patients will receive three ketamine booster infusions over the course of three months.
Other Names:
  • Ketamine
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.
Drug: Control Group + Epidural infusion
The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Other Names:
  • Epidural
Drug: Control Group Booster Infusion
Patients will receive three saline booster infusions over the course of three months.
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Reduction
Time Frame: 6 months post infusion
Evidence of changes in NRS pain scores between baseline and six months post infusion
6 months post infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Daniel I Richman, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2014

Primary Completion (Actual)

April 20, 2015

Study Completion (Actual)

April 20, 2015

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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