NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Intravenous Lidocaine; Drug: Normal saline infusion

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Hopital Maisonneuve Rosemont
      • Contact: Nadia godin; Phone Number: 3153 1 514 252 3400; Email: ngodin.hmr@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Intravenous Lidocaine; Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h; Other Names: Chlorydrate de Lidocaine 2%
Placebo Comparator: Placebo; Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Louis-Philippe Fortier, M.D., Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: February 27, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Estimate): April 26, 2013
• Last Update Submitted That Met QC Criteria: April 25, 2013
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 11077 (DAIDS ES Registry Number)