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

NCT02094352 | Terminated Phase 2 Results DMC

• 1 other identifier: 2013-003
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Complex Regional Pain Syndrome

Keywords

Complex Regional Pain Syndrome; Pain management; Ketamine infusion

Outcome Measures

Primary Outcomes (1)

• Pain Reduction

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

  6 months post infusion

Study Arms (2)

Ketamine Infusion + Epidural Infusion + Booster Infusion

EXPERIMENTAL

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.

Drug: Ketamine Infusion + Epidural Infusion; Drug: Ketamine Booster Infusion

Control Group + Epidural Infusion + Booster Infusion

PLACEBO COMPARATOR

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.

Drug: Control Group + Epidural infusion; Drug: Control Group Booster Infusion

Interventions

Ketamine Infusion + Epidural Infusion DRUG

The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.

Also known as: Ketamine, Epidural

Ketamine Infusion + Epidural Infusion + Booster Infusion

Control Group + Epidural infusion DRUG

The saline and epidural infusions will be administered over 96 hours with appropriate titration.

Also known as: Epidural

Control Group + Epidural Infusion + Booster Infusion

Ketamine Booster Infusion DRUG

Patients will receive three ketamine booster infusions over the course of three months.

Also known as: Ketamine

Ketamine Infusion + Epidural Infusion + Booster Infusion

Control Group Booster Infusion DRUG

Patients will receive three saline booster infusions over the course of three months.

Also known as: Saline

Control Group + Epidural Infusion + Booster Infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Links

• Hospital for Special Surgery

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Agnosia

Interventions

Ketamine; Injections, Epidural; Control Groups; Sodium Chloride

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Richman
• Organization: HSS

RichmanD@HSS.EDU

212.517.4481

Study Officials

• Daniel I Richman, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: March 21, 2014
• Study Start: March 24, 2014
• Primary Completion: April 20, 2015
• Study Completion: April 20, 2015
• Last Updated: January 31, 2018
• Results First Posted: June 14, 2017

Record last verified: 2018-01

Locations

US (1)