Clinical trial NCT01841294: NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery
Official title: NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Cancer
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dosage of NKs activity after surgery
timeFrame: compare the activity of NK cells on day 1 and day 3 after surgery
Secondary outcomes:
measure: Pain scores
timeFrame: pain scores from the PACU to the 3rd day after surgery
measure: Morphine consumption
timeFrame: From the PACU to the 3rd day after surgery
measure: Ileus time
timeFrame: Day 1 and Day 3 after surgery
measure: Surgical complications
timeFrame: Within 3 days after surgery
measure: Fentanyl dose
timeFrame: Operative time
measure: Nausea and vomiting
timeFrame: From the PACU to the 3rd day after surgery
measure: Major adverses events
timeFrame: Start of the surgery untill one hour after PACU ad;ission
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital Maisonneuve Rosemont
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Louis-Philippe Fortier, M.D.
role: PRINCIPAL_INVESTIGATOR
References: