Status:
ACTIVE_NOT_RECRUITING
Perioperative Lidocaine and Ketamine in Abdominal Surgery
Lead Sponsor:
The Cleveland Clinic
Conditions:
Postoperative Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 abdomi...
Detailed Description
The investigators propose a prospective, randomized, double-blind, placebo-controlled clinical trial (RCT) with a factorial design. Adults 18 to 80 years old having elective inpatient open or laparosc...
Eligibility Criteria
Inclusion
- Adults 18 to 80 years old
- Elective inpatient open or laparoscopic abdominal surgery
- General anesthesia lasting 2 hours or longer.
Exclusion
- 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
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04084548
Start Date
October 15 2019
End Date
December 1 2025
Last Update
May 21 2025
Active Locations (1)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331