Perioperative Lidocaine and Ketamine in Abdominal Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lidocaine and Ketamine in Abdominal Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Lidocaine and ketamine
* Drug: Lidocaine
* Drug: Ketamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Double-blind factorial randomization to lidocaine or placebo and ketamine or placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine and placebo<br>Lidocaine and placebo | Drug: Lidocaine<br>* 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)<br>|
| Experimental: Ketamine and placebo<br>Ketamine and placebo | Drug: Ketamine<br>* 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)<br>|
| Experimental: Lidocaine and ketamine<br>Lidocaine and ketamine | Drug: Lidocaine and ketamine<br>* Perioperative lidocaine and ketamine infusion (see below for dosages and timings)<br>|
| Placebo Comparator: Placebo and placebo<br>Placebo and placebo | Drug: Placebo<br>* Perioperative placebo infusion (normal saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | 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. | 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 | 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. | First postoperative 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall benefit of analgesia score (OBAS) | 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. | First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings). | 
| Quality of recovery (QoR-15) score | 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. | First postoperative 48 hours (measured at the end of the PACU stay as well as on the 1st and 2nd postoperative mornings). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multimodal analgesia, Lidocaine, Ketamine, Abdominal surgery