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

Primary Purpose

Complex Regional Pain Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine Infusion + Epidural Infusion
Control Group + Epidural infusion
Ketamine Booster Infusion
Control Group Booster Infusion
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome focused on measuring Complex Regional Pain Syndrome, Pain management, Ketamine infusion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine Infusion + Epidural Infusion + Booster Infusion

Control Group + Epidural Infusion + Booster Infusion

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 23, 2013
Last Updated
January 8, 2018
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT02094352
Brief Title
Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome
Official Title
Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was unable to enroll efficiently despite trying various technique.
Study Start Date
March 24, 2014 (Actual)
Primary Completion Date
April 20, 2015 (Actual)
Study Completion Date
April 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Receives epidural infusion 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome
Keywords
Complex Regional Pain Syndrome, Pain management, Ketamine infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine Infusion + Epidural Infusion + Booster Infusion
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group + Epidural Infusion + Booster Infusion
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine Infusion + Epidural Infusion
Other Intervention Name(s)
Ketamine, Epidural
Intervention Description
The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
Intervention Type
Drug
Intervention Name(s)
Control Group + Epidural infusion
Other Intervention Name(s)
Epidural
Intervention Description
The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Intervention Type
Drug
Intervention Name(s)
Ketamine Booster Infusion
Other Intervention Name(s)
Ketamine
Intervention Description
Patients will receive three ketamine booster infusions over the course of three months.
Intervention Type
Drug
Intervention Name(s)
Control Group Booster Infusion
Other Intervention Name(s)
Saline
Intervention Description
Patients will receive three saline booster infusions over the course of three months.
Primary Outcome Measure Information:
Title
Pain Reduction
Description
Evidence of changes in NRS pain scores between baseline and six months post infusion
Time Frame
6 months post infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel I Richman, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.hss.edu
Description
Hospital for Special Surgery

Learn more about this trial

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

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