Perioperative Lidocaine and Ketamine in Abdominal Surgery

NeuroTherapia, Inc.

Status and phase: Active, not recruiting; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Lidocaine and ketamine; Drug: Placebo; Drug: Ketamine; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04084548

FLA 18-088

Details and patient eligibility

About

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.

Full 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 laparoscopic abdominal surgery with general anesthesia lasting 2 hours or longer will be included in this study.

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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420 participants in 4 patient groups, including a placebo group

Lidocaine and placebo

Experimental group

Description:

Lidocaine and placebo

Treatment:

Drug: Lidocaine

Ketamine and placebo

Experimental group

Description:

Ketamine and placebo

Treatment:

Drug: Ketamine

Lidocaine and ketamine

Experimental group

Description:

Lidocaine and ketamine

Treatment:

Drug: Lidocaine and ketamine

Placebo and placebo

Placebo Comparator group

Description:

Placebo and placebo

Treatment:

Drug: Placebo