Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
Opioid Dependence, Chronic Pain
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring Ketamine, Lumbar Spine Surgery, Opioid Tolerant
Eligibility Criteria
Inclusion Criteria
- Patients undergoing lumbar, thoracic or cervical spine surgery of at least one level, and no more than 6 levels.
- Patients with chronic back pain (>3 months)
- Anaesthetic risk assessment (ASA) 1-3
- Opiate-dependent with daily opiate use for at least 2 months and regimented daily narcotic dose twice a day/bis in die (BID) or greater or use of a regimented opioid pump
Exclusion Criteria
- Intolerance or known allergy to ketamine
- History of increased intraocular pressure (> 22mmHg)
- Uncontrolled hypertension (systolic blood pressure greater than or equal to 180, diastolic blood pressure greater than equal to 100)
- Increased intracranial pressure
- History of psychosis
- Pregnancy
- Patients with significant liver disease {signs and symptoms of liver injury, such as discolored skin and eyes that appear yellowish, abdominal pain and swelling, Itchy skin that doesn't seem to go away, dark urine color, pale stool color, bloody or tar-colored stool, chronic fatigue, nausea, loss of appetite, with or without elevated Liver Function Tests (LFTs): aspartate aminotransferase (AST) > 120 IU/ml, alkaline phosphatase (AP) >130 IU/ml, and alanine aminotransferase (ALT) >40 IU/ml}
- Patients with exposure to Cytochrome P450, family 3, subfamily A (CYP3A) and / or Cytochrome P450 Family 2 Subfamily B Member 6 (CYP2B6) inhibitors, including the herbs and the over-the-counter compounds (list of drugs can be found at http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm)
Sites / Locations
- Jacques E Chelly, MD
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ketamine Group
Placebo Group
Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure).
Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure).