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

Complex Regional Pain Syndrome Clinical Trial

Official title:

Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02094352
• Other study ID #: 2013-003
• Status: Terminated
• Phase: Phase 2
• First received: December 23, 2013
• Last updated: January 8, 2018
• Start date: March 24, 2014
• Est. completion date: April 20, 2015

Study information

• Verified date: January 2018
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 20, 2015
• Est. primary completion date: April 20, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Reduction	Evidence of changes in NRS pain scores between baseline and six months post infusion	6 months post infusion

External Links

•   Hospital for Special Surgery