Complex Regional Pain Syndome type 1 (CRPS 1)
Conditions
Interventions
Subjects are assigned to receive either intravenous (S+)-ketamine or placebo.
Sponsors
Leiden University Medical Center, dep. Anaesthesiology
Eligibility
Inclusion criteria
Inclusion criteria: Patients will be male or female adult patients with a clinical diagnosis of CRPS 1 who are referred to the pain centre outpatients' clinic of the department of Anaesthesiology at the LUMC. 1. Patients should fulfill the diagnostic criteria of the consensus report of CRPS 1: a. continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event, b. evidence at some time of edema, changes in skin blood flow or abnormal sudomotor activity in the region of the pain and c. no condition that would otherwise account for the degree of pain and dysfunction. 2. Patients must report a VAS-spontaneous pain score of 5 cm or higher. 3. Patients’ age is between 18 and 70 years. 4. Onset of symptoms must be shorter than 6 months or longer than 3 years before inclusion. 5. Patients should give a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are not able to give informed consent. 2. Patients suffering from other pain syndromes, interfering with pain ratings. 3. Patients suffering from other syndromes interfering with pain ratings. 4. Patients suffering from a kidney and/or severe liver disease. 5. Patients suffering from nerve damage in the affected area. 6. Patients with an active infection. 7. Patients with high intracranial pressure. 8. Patients with epilepsy. 9. Patients with a psychiatric illness. 10. Patients with thyroid disease. 11. Patients with cancer. 12. Patients with cardiac disease. 13. Patients with pulmonary disease. 14. Patients with glaucoma. 15. Patients with a history of cerebral vascular accident (CVA). 16. Patients who are a pregnant. 17. Strong-opioid consumption (step one and two of the WHO pain ladder is allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Painreduction measured by numerical rating scale (0 no pain, 10 worst imaginable pain). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary aims of the study deal with: 1. The role of NMDA receptor activation in the autonomic and motor features of CRPS; 2. To establish the endurance of ketamine on the impairments of CRPS; 3. To study the pharmacokinetics and pharmacodynamics of ketamine in subanaesthetic doses; 4. To establish data for future pragmatic studies on ketamine i.v. in patients with CRPS on the levels of disability and safety. | — |
Contacts
Public ContactM.J. Sigtermans
Leiden University Medical Center (LUMC), Department of Anaesthesiology, P.O. Box 9600
Outcome results
None listed