Recruiting

Lidocaine

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT01841294

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intravenous Lidocaine

Normal saline infusion

Study Details

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.

Conditions

Colorectal Cancer

Study ID

NCT01841294

Start date

Jan, 2012

Status verified date

Jan, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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

placebo comparator: Placebo

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

Interventions

Intravenous Lidocaine

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

Normal saline infusion

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

Primary outcome measure

  • Dosage of NKs activity after surgery [ Time Frame: compare the activity of NK cells on day 1 and day 3 after surgery ]

Central Contacts and Locations

Central contacts

louis-Philippe Fortier, M.D.

1 514 252 3400fortierlp@mac.com

Locations

Hôpital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Nadia godin

1 514 252 3400ngodin.hmr@ssss.gouv.qc.ca

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Apr 26, 2013

Last verified

Jan, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2013-04-26.