Clinical Trial for Complex Regional Pain Syndrome (CRPS) with IV Ketamine

CRPS RSD CLINICAL TRIAL Medical Symbol Asclepius Caduceus
CRPS RSD CLINICAL TRIAL Medical Symbol Asclepius Caduceus

The Hospital for Special Surgery, New York is conducting a Randomized Controlled Trial of

Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome.

This study is currently recruiting participants.

Please read the study inclusion & exclusion criteria shown below carefully prior to contacting the clinical trial organizers.
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
The purpose of this study is to determine whether epidural and ketamine infusions are effective in the treatment of Complex Regional Pain Syndrome (CRPS).
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Complex Regional Pain Syndrome
  • 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
  • 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
Recruiting
60
Not Provided
December 2017   (final data collection date for primary outcome measure)
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
Both
18 Years to 65 Years
Yes
Contact: Estioco, BSN   646 714 6270       estiocok@hss.edu
United States
NCT02094352
2013-003
Yes
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Not Provided
Principal Investigator:    Richman, MD   Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
October 2014

 

10 responses to “Clinical Trial for Complex Regional Pain Syndrome (CRPS) with IV Ketamine”

  1. Thank you for sharing this! I posted your link on my support group pg.

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  2. I have had this for 20 years.I have been treated by Dr O’Malley and Dr Richman. I have been looking at the ketamine for a few months now. I had to stop treatment with Dr Richman for financial reasons. Please consider me. I can be reached at . Thank you

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    1. Hi Cheryl, you will need to contact the folks who are hosting the trial directly to see if they have a place for you.

      Contact: Estioco, BSN 646 714 6270 estiocok@hss.edu

      Like

  3. I would like to participate

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    1. Hi Susan, you will need to contact the folks who are hosting the trial directly to see if they have a place for you.

      Contact: Estioco, BSN 646 714 6270 estiocok@hss.edu

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  4. I would like to be considered for this trial. I am a 44 year old female with a confirmed diagnosis of C.R.P.S..

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    1. Hi RM, you will need to contact the folks who are hosting the trial to see if they have a place for you.

      Contact: Estioco, BSN 646 714 6270 estiocok@hss.edu

      Like

  5. I fit your criteria perfectly and alrady have a port placed! I have full body/systemic RSD

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    1. Hi Missy, you will need to contact the folks who are hosting the trial to see if they have a place for you.

      Contact: Estioco, BSN 646 714 6270 estiocok@hss.edu

      Like

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