Perioperative Lidocaine and Ketamine in Abdominal Surgery

Overview

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.

Full Title of Study: “Lidocaine and Ketamine in Abdominal Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2021

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.

Interventions

  • Drug: Lidocaine and ketamine
    • Perioperative lidocaine and ketamine infusion (see below for dosages and timings)
  • Drug: 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)
  • Drug: 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)
  • Drug: Placebo
    • Perioperative placebo infusion (normal saline)

Arms, Groups and Cohorts

  • Experimental: Lidocaine and placebo
    • Lidocaine and placebo
  • Experimental: Ketamine and placebo
    • Ketamine and placebo
  • Experimental: Lidocaine and ketamine
    • Lidocaine and ketamine
  • Placebo Comparator: Placebo and placebo
    • Placebo and placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Cleveland Clinic
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rebecca Y Wong, MBBS, MPH, Principal Investigator, Cleveland Clinic Florida
  • Overall Contact(s)
    • Rebecca Y Wong, MBBS, MPH, 954-789-8933, wongr3@ccf.org

References

Grady MV, Mascha E, Sessler DI, Kurz A. The effect of perioperative intravenous lidocaine and ketamine on recovery after abdominal hysterectomy. Anesth Analg. 2012 Nov;115(5):1078-84. doi: 10.1213/ANE.0b013e3182662e01. Epub 2012 Sep 25.

Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6:CD009642. doi: 10.1002/14651858.CD009642.pub3. Review.

Elia N, Tramèr MR. Ketamine and postoperative pain–a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. Review.

Ye F, Wu Y, Zhou C. Effect of intravenous ketamine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy: A meta-analysis. Medicine (Baltimore). 2017 Dec;96(51):e9147. doi: 10.1097/MD.0000000000009147. Review.

Zhao JB, Li YL, Wang YM, Teng JL, Xia DY, Zhao JS, Li FL. Intravenous lidocaine infusion for pain control after laparoscopic cholecystectomy: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Feb;97(5):e9771. doi: 10.1097/MD.0000000000009771.

Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8. Erratum in: Dis Colon Rectum. 2013 Feb;52(2):271.

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