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

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ClinicalTrials.gov Identifier: NCT02094352
Recruitment Status : Terminated (The study was unable to enroll efficiently despite trying various technique.)
First Posted : March 21, 2014
Results First Posted : June 14, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date  ICMJE December 23, 2013
First Posted Date  ICMJE March 21, 2014
Results First Submitted Date  ICMJE March 21, 2017
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date January 31, 2018
Actual Study Start Date  ICMJE March 24, 2014
Actual Primary Completion Date April 20, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
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 Measures  ICMJE
 (submitted: March 20, 2014)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome
Official Title  ICMJE Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Complex Regional Pain Syndrome
Intervention  ICMJE
  • Drug: Ketamine Infusion + Epidural Infusion
    The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
    Other Names:
    • Ketamine
    • Epidural
  • Drug: Control Group + Epidural infusion
    The saline and epidural infusions will be administered over 96 hours with appropriate titration.
    Other Name: Epidural
  • Drug: Ketamine Booster Infusion
    Patients will receive three ketamine booster infusions over the course of three months.
    Other Name: Ketamine
  • Drug: Control Group Booster Infusion
    Patients will receive three saline booster infusions over the course of three months.
    Other Name: Saline
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Ketamine Infusion + Epidural Infusion
    • Drug: Ketamine Booster Infusion
  • 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.

    Interventions:
    • Drug: Control Group + Epidural infusion
    • Drug: Control Group Booster Infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2016)
3
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2014)
60
Actual Study Completion Date  ICMJE April 20, 2015
Actual Primary Completion Date April 20, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02094352
Other Study ID Numbers  ICMJE 2013-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel I Richman, MD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP