Colorectal Cancer
Conditions
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.
Interventions
Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
Normal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
Sponsors
Maisonneuve-Rosemont Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pain scores | pain scores from the PACU to the 3rd day after surgery | From the PACU to the 3rd day after 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 |
| Fentanyl dose | Operative time | Cumulative dose of fentanyl needed for the surgery |
Countries
Canada
Contacts
Primary Contactlouis-Philippe Fortier, M.D.
Outcome results
None listed