Perioperative Lidocaine and Ketamine in Abdominal Surgery

Ketamine

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.

Intervention / Treatment

Double-blind factorial randomization to lidocaine or placebo and ketamine or placebo.
  • 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)

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 80 Years
    Enrollment: 420 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Pharmacy-prepared medications.

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Oct 15, 2019 ACTUAL
    Primary Completion: Dec 01, 2023 ESTIMATED
    Completion Date: Dec 01, 2023 ESTIMATED
    Study First Posted: Sep 10, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Feb 13, 2023

    Sponsors / Collaborators

    Lead Sponsor: The Cleveland Clinic
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Weston, Florida, USA

    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.

    Participant Groups

    • Lidocaine and placebo

    • Ketamine and placebo

    • Lidocaine and ketamine

    • Placebo and placebo

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 80
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • 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 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

    • 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.

    • 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

    • Measured in minutes

    • Measured in days

    • Measured as dichotomous outcome (yes/no)

    More Details

    NCT Number: NCT04084548
    Other IDs: FLA 18-088
    Study URL: https://clinicaltrials.gov/study/NCT04084548
    Last updated: Sep 29, 2023