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Active Not Recruiting
NCT04084548
Perioperative Lidocaine and Ketamine in Abdominal Surgery
Conditions: Postoperative Pain
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 420
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Florida Weston Florida
Summary
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.
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
Source: ClinicalTrials.gov (NCT04084548). StuddyBuddy aggregates publicly available trial information.