Clinical trial

Lidocaine and Ketamine in Abdominal Surgery

Name

FLA 18-088

Description

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.

Trial arms

Trial start

2019-10-15

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Lidocaine and ketamine

Perioperative lidocaine and ketamine infusion (see below for dosages and timings)

Arms:

Lidocaine and ketamine

Lidocaine

Perioperative lidocaine infusion (1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU)

Arms:

Lidocaine and placebo

Ketamine

Perioperative ketamine infusion (0.5 mg/kg bolus followed by an infusion of 0.3 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU)

Arms:

Ketamine and placebo

Placebo

Perioperative placebo infusion (normal saline)

Arms:

Placebo and placebo

Size

420

Primary endpoint

Pain scores

First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).

Total opioid consumption

First postoperative 48 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Double-blind factorial randomization to lidocaine or placebo and ketamine or placebo.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Pharmacy-prepared medications.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 420, 'type': 'ESTIMATED'}}

Updated at

2024-06-06

1 organization

3 products

1 drug

1 indication

Organization

Product

Indication

Product

Drug

Product