NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

Overview

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.

Full Title of Study: “NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 2013

Interventions

  • Drug: Intravenous Lidocaine
    • Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
  • Drug: Normal saline infusion
    • Normal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h

Arms, Groups and Cohorts

  • Experimental: Intravenous Lidocaine
    • 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
  • Placebo Comparator: Placebo
    • Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission

Clinical Trial Outcome Measures

Primary Measures

  • Dosage of NKs activity after surgery
    • Time Frame: compare the activity of NK cells on day 1 and day 3 after surgery
    • Dosage of NKs activity after surgery

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maisonneuve-Rosemont Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Louis-Philippe Fortier, Principal investigator – Maisonneuve-Rosemont Hospital
  • Overall Official(s)
    • Louis-Philippe Fortier, M.D., Principal Investigator, Maisonneuve-Rosemont Hospital
  • Overall Contact(s)
    • louis-Philippe Fortier, M.D., 1 514 252 3400, fortierlp@mac.com

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