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NCT Number: NCT04084548

Perioperative Lidocaine and Ketamine in Abdominal Surgery

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine and ketamine

Drug

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

Lidocaine

Drug

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)

ketamine

Drug

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)

Placebo

Drug

Perioperative placebo infusion (normal saline)

Primary outcomes

  1. Pain scores

    Time frame: 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.

  2. Total opioid consumption

    Time frame: 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 outcomes

  1. Overall benefit of analgesia score (OBAS)

    Time frame: 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.

  2. Quality of recovery (QoR-15) score

    Time frame: 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.

Other outcomes

  1. Time to first opioid administration

    Time frame: The amount of time from PACU admission to PACU discharge

    Measured in minutes

  2. Postoperative hospital length of stay

    Time frame: The number of days from hospital admission to hospital discharge

    Measured in days

  3. Nausea or vomiting

    Time frame: First postoperative 48 hours

    Measured as dichotomous outcome (yes/no)

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Lidocaine and Ketamine in Abdominal Surgery

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2019
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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