NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery
- Conditions
- Colorectal Cancer
- Interventions
- Drug: Normal saline infusion
- Registration Number
- NCT01841294
- Lead Sponsor
- Maisonneuve-Rosemont Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Normal saline infusion Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission Intravenous Lidocaine 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
- Primary Outcome Measures
Name Time Method Dosage of NKs activity after surgery compare the activity of NK cells on day 1 and day 3 after surgery Dosage of NKs activity after surgery
- Secondary Outcome Measures
Name Time Method Pain scores pain scores from the PACU to the 3rd day after surgery From the PACU to the 3rd day after surgery
Morphine consumption From the PACU to the 3rd day after surgery Morphine consumption from the PACU to the 3rd day after surgery
Ileus time Day 1 and Day 3 after surgery time to get flattus after surgery
Surgical complications Within 3 days after surgery Infections, leakage, abcess
Fentanyl dose Operative time Cumulative dose of fentanyl needed for the surgery
Nausea and vomiting From the PACU to the 3rd day after surgery Nausea and vomiting from the PACU to the 3rd day after surgery
Major adverses events Start of the surgery untill one hour after PACU ad;ission Hypotension, heart rythm blocks, tachycarida, bradycardia
Trial Locations
- Locations (1)
Hôpital Maisonneuve Rosemont
🇨🇦Montreal, Quebec, Canada