Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Opioid Dependence, Chronic Pain

In brief

The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in chronic back pain patients undergoing spinal laminectomy/fusion when compared to placebo Opioid dependence will be defined as daily opioid use (2 or more doses per day) for a period of two-months or longer. Intraoperatively, patients will receive a 1 mg/kg dose of intravenous ketamine or saline with 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 or saline will be run to conclude at 24 hours after the end of the surgery (fascial closure). The primary outcome measure will be hydromorphone PCA usage during the first 72 hours postoperatively. Secondary outcome measures will be VAS pain scores at rest and with movement in PACU, 24 hr, 48 hr, 72 hr, 2 week (post-op visit), 6 week follow-up visit, as well as, McGill Pain Questionnaire, Pain Catastrophizing Scale, and emotional distress surveys assessing depression and anxiety at preop/screening, postop and 6 week follow-up (PROMIS Emotional Distress-Anxiety Short Form, PROMIS Emotional Distress-Depression Short Form), as well as a Neuro-QOL Short Form v1.1 - Satisfaction with Social Roles and Activities .

Key facts

Study ID: NCT04220489
Run by: Jacques E. Chelly
People needed: 1
Starts: 2019-12-17
Expected to finish: 2022-11-19
Last updated by the study team: 2024-01-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Jacques E Chelly, MD — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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