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

Information source: Hospital for Special Surgery, New York
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complex Regional Pain Syndrome

Intervention: Ketamine Infusion + Epidural Infusion (Drug); Control Group + Epidural infusion (Drug); Ketamine Booster Infusion (Drug); Control Group Booster Infusion (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Hospital for Special Surgery, New York

Official(s) and/or principal investigator(s):
Daniel I Richman, MD, Principal Investigator, Affiliation: Hospital for Special Surgery, New York


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Pain reduction

Secondary outcome:

Improved pain-related quality of life and mental status


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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.



- 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

Locations and Contacts

Hospital for Special Surgery, New York, New York 10021, United States
Additional Information

Hospital for Special Surgery

Starting date: April 2014
Last updated: April 27, 2015

Page last updated: August 23, 2015

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