Active, Not RecruitingPhase 3ketamine
Perioperative Lidocaine and Ketamine in Abdominal Surgery
Sponsored by The Cleveland Clinic
NCT ID
NCT04084548
Target Enrollment
420 participants
Start Date
2019-10-15
Est. Completion
2025-12
About This Study
The investigators propose to test the hypothesis that perioperative infusions of lidocaine and/or ketamine reduce opioid consumption and pain scores in adults recovering from elective inpatient abdominal surgery.
Conditions Studied
Interventions
- •Lidocaine and ketamine
- •Lidocaine
- •Ketamine
- •Placebo
Eligibility
Age:18 Years - 80 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria: * Adults 18 to 80 years old * Elective inpatient open or laparoscopic abdominal surgery * General anesthesia lasting 2 hours or longer. Exclusion Criteria: * 1\. Planned postoperative mechanical ventilation * 2\. Planned regional anesthesia/analgesia * 3\. Perioperative gabapentin, magnesium, or nitrous oxide use * 4\. Pregnancy or breastfeeding * 5\. Morbid obesity (BMI ≥ 35 kg/m2) * 6\. American Society of Anesthesiologists (ASA) physical status IV-V * 7\. Allergy to study medications * 8\. Contraindication to lidocaine (severe cardiac arrhythmia) * 9\. Contraindication to ketamine (psychiatric disorder, substance abuse, uncontrolled hypertension, pulmonary hypertension, increased intracranial or intraocular pressure, use of monoamine oxidase inhibitors) * 10\. Chronic preoperative opioid use (≥ 90 morphine mg equivalents per day for \> 3 months) * 11\. Significant preoperative hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels \> 5 times normal) or planned liver transplantation * 12\. Preoperative cardiac failure (left ventricular ejection fraction ≤ 40%) * 13\. Unable to communicate or comprehend study instructions
Study Locations (1)
Cleveland Clinic Florida
Weston, Florida, United States