Suspended

NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery

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What is being tested

Intravenous Lidocaine

+ Normal saline infusion

Drug
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

From 18 to 80 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 4
Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorMaisonneuve-Rosemont Hospital
Study Contactlouis-Philippe Fortier, M.D.More contacts
Last updated: April 26, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorMaisonneuve-Rosemont Hospital
Study Contactlouis-Philippe Fortier, M.D.More contacts
Last updated: April 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

3 inclusion criteria required to participate
American Society of Anesthesiologists class I-III

Patients admitted for resection of colorectal cancer under laparoscopic surgery

The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent

14 exclusion criteria prevent from participating
Advanced heart block (unless patient has a pacemaker)

BMI > 35 kg/m2

Electrocardiographic abnormalities

Emergent procedure

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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

Group II

Placebo
Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hôpital Maisonneuve Rosemont

Montreal, CanadaOpen Hôpital Maisonneuve Rosemont in Google Maps
SuspendedOne Study Center