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

Ketamine

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).

Intervention / Treatment

  • Ketamine Infusion + Epidural Infusion (DRUG)
    The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
  • Control Group + Epidural infusion (DRUG)
    The saline and epidural infusions will be administered over 96 hours with appropriate titration.
  • Ketamine Booster Infusion (DRUG)
    Patients will receive three ketamine booster infusions over the course of three months.
  • Control Group Booster Infusion (DRUG)
    Patients will receive three saline booster infusions over the course of three months.

Condition or Disease

  • Complex Regional Pain Syndrome

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 3 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Mar 24, 2014 ACTUAL
    Primary Completion: Apr 20, 2015 ACTUAL
    Completion Date: Apr 20, 2015 ACTUAL
    Study First Posted: Mar 21, 2014 ESTIMATED
    Results First Posted: Jun 14, 2017 ACTUAL
    Last Updated: Jan 08, 2018

    Sponsors / Collaborators

    Lead Sponsor: Hospital for Special Surgery, New York
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    New York, New York, USA

    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.

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

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

    More Details

    NCT Number: NCT02094352
    Other IDs: 2013-003
    Study URL: https://clinicaltrials.gov/study/NCT02094352
    Last updated: Sep 29, 2023