NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

Study Overview
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Brief Summary
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Surgical resection is the best treatment option for colorectal cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the immunosuppressive state surrounding the perioperative period was a key element of cancer cells spread. A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of the innate immune system. Several factors of the perioperative period can reduce activity of NKs such as stress, pain, opioids and general anaesthetics. Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption, ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic inflammation as well. The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries for colorectal cancer resection will preserve NKs activity.

Official Title
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NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Intravenous Lidocaine
* Drug: Normal saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted for resection of colorectal cancer under laparoscopic surgery American Society of Anesthesiologists class I-III. The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent. Exclusion Criteria: Subjects allergic to any of the study drugs. BMI > 35 kg/m2. Severe renal or hepatic failure. Pregnancy. Emergent procedure. Heart failure NYHA > III. Systolic blood pressure < 90 mmHg. Advanced heart block (unless patient has a pacemaker). Unstable angina and/or myocardial infarction within past 6 weeks. FEV1 ≤ 0.8 L. Oxygen-dependent patient. Electrocardiographic abnormalities Treatment with immunosupressive drugs, corticosteroids, NSAIDS, antiarythmic Morphine intolerance or allergy

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Lidocaine<br>Patients undergoing laparoscopic surgery for resection of colorectal cancer will benefit of an infusion of intravenous lidocaine from the induction of anesthesia untill one hour after PACU admission | Drug: Intravenous Lidocaine<br>* Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h<br>* Other names: Chlorydrate de Lidocaine 2%;|
| Placebo Comparator: Placebo<br>Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission | Drug: Normal saline infusion<br>* Normal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of NKs activity after surgery | Dosage of NKs activity after surgery | compare the activity of NK cells on day 1 and day 3 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | From the PACU to the 3rd day after surgery | pain scores from the PACU to the 3rd day after surgery | 
| Morphine consumption | Morphine consumption from the PACU to the 3rd day after surgery | From the PACU to the 3rd day after surgery | 
| Ileus time | time to get flattus after surgery | Day 1 and Day 3 after surgery | 
| Surgical complications | Infections, leakage, abcess | Within 3 days after surgery | 
| Fentanyl dose | Cumulative dose of fentanyl needed for the surgery | Operative time | 
| Nausea and vomiting | Nausea and vomiting from the PACU to the 3rd day after surgery | From the PACU to the 3rd day after surgery | 
| Major adverses events | Hypotension, heart rythm blocks, tachycarida, bradycardia | Start of the surgery untill one hour after PACU ad;ission |