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

Postoperative Pain

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

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source