Complex Regional Pain Syndrome
Conditions
Keywords
Complex Regional Pain Syndrome, Pain management, Ketamine infusion
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: 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.
Interventions
DRUGKetamine Infusion + Epidural Infusion
The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
DRUGControl Group + Epidural infusion
The saline and epidural infusions will be administered over 96 hours with appropriate titration.
DRUGKetamine Booster Infusion
Patients will receive three ketamine booster infusions over the course of three months.
DRUGControl Group Booster Infusion
Patients will receive three saline booster infusions over the course of three months.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | 6 months post infusion | Evidence of changes in NRS pain scores between baseline and six months post infusion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Infusion + Epidural Infusion + Booster Infusion 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.
Ketamine Infusion + Epidural Infusion: The ketamine 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. | 2 |
| Control Group + Epidural Infusion + Booster Infusion 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.
Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months. | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Ketamine Infusion + Epidural Infusion + Booster Infusion | Control Group + Epidural Infusion + Booster Infusion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Pain Reduction
Evidence of changes in NRS pain scores between baseline and six months post infusion
Time frame: 6 months post infusion
Population: Study terminated early due to lack of enrollment. We did not analyze any data.