NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

NCT ID: NCT01841294

Last Updated: 2013-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Intravenous Lidocaine

Intervention Type DRUG

Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h

Placebo

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

Group Type PLACEBO_COMPARATOR

Normal saline infusion

Intervention Type DRUG

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

Interventions

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Intravenous Lidocaine

Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Chlorydrate de Lidocaine 2%

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Louis-Philippe Fortier

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louis-Philippe Fortier, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

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Hôpital Maisonneuve Rosemont

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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louis-Philippe Fortier, M.D.

Role: CONTACT

1 514 252 3400

Facility Contacts

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Nadia godin

Role: primary

1 514 252 3400 ext. 3153

Other Identifiers

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11077

Identifier Type: -

Identifier Source: org_study_id

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