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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hospital for Special Surgery, New York
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT02094352
First received: December 23, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Complex Regional Pain Syndrome
Drug: Ketamine Infusion + Epidural Infusion
Drug: Control Group + Epidural infusion
Drug: Ketamine Booster Infusion
Drug: Control Group Booster Infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 6 months post infusion ] [ Designated as safety issue: No ]
    Evidence of changes in NRS pain scores between baseline and six months post infusion


Secondary Outcome Measures:
  • Improved pain-related quality of life and mental status [ Time Frame: 6 months post infusion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Verify the safety of dosing as defined in the protocol (e.g., adverse events, complications).


Estimated Enrollment: 60
Study Start Date: April 2014
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Epidural
Drug: Control Group Booster Infusion
Patients will receive three saline booster infusions over the course of three months.
Other Name: Saline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02094352

Contacts
Contact: Estioco, BSN estiocok@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Kaye Estioco       estiocok@hss.edu   
Sub-Investigator: Jodie Curren, BSN         
Sub-Investigator: Robert Griffin, MD         
Sub-Investigator: Vladimir Kramskiy, MD         
Sub-Investigator: Christine Peterson, MD         
Sub-Investigator: Seth Waldman, MD         
Principal Investigator: Daniel Richman, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Richman, MD Hospital for Special Surgery, New York
  More Information

Additional Information:
No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02094352     History of Changes
Other Study ID Numbers: 2013-003
Study First Received: December 23, 2013
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Hospital for Special Surgery, New York:
Complex Regional Pain Syndrome
Pain management
Ketamine infusion

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Somatoform Disorders
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014