Perioperative Lidocaine and Ketamine in Abdominal Surgery

Phase 3

Active, not recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Lidocaine and ketamine; Drug: Placebo; Drug: Lidocaine; Drug: Ketamine

• Registration Number: NCT04084548
• Lead Sponsor: The Cleveland Clinic

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 abdominal surgery.

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

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-10
• Study Start: 2019-10-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 420

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Lidocaine and ketamine	Lidocaine and ketamine	Lidocaine and ketamine
Placebo and placebo	Placebo	Placebo and placebo
Lidocaine and placebo	Lidocaine	Lidocaine and placebo
Ketamine and placebo	Ketamine	Ketamine and placebo

Primary Outcome Measures

Name	Time	Method
Pain scores	First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).	Pain scores based on the visual analog scale and Brief Pain Inventory. Ranges from 0 to 10, with 0 being no pain and 10 being the worst imaginable pain. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.
Total opioid consumption	First postoperative 48 hours	Total opioid consumption in oral morphine equivalents (mg) from the time of transfer to PACU through to the second postoperative morning. The intervention will be deemed effective if both outcomes are non-inferior, and at least one is superior, to the control group.

Secondary Outcome Measures

Name	Time	Method
Quality of recovery (QoR-15) score	First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).	Measures 15 different items, i.e. ability to breathe easily, enjoy food, feel rested, have a good sleep, look after personal toilet and hygiene unaided, communicate with family or friends, getting support from hospital doctors and nurses, return to work or usual home activities, feel comfortable and in control, have a feeling of general well-being, as well as the presence of moderate pain, severe pain, nausea or vomiting, feeling worried or anxious, and feeling sad or depressed. Each item is scored from 0 to 10, with a total QoR-15 score ranging from 0 to 150. The higher the QoR-15 score, the better the quality of recovery in the postoperative period.
Overall benefit of analgesia score (OBAS)	First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings).	Measures 7 different items, i.e. current pain, vomiting, itching, sweating, freezing, dizziness, and patient satisfaction related to pain management. Each item is scored from 0 to 4, with the total OBAS score ranging from 0 to 28. The lower the total OBAS score, the higher the benefit of analgesia.

Trial Locations

Locations (1)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States