NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

NCT01841294 | Unknown Phase 4 DMC

• 1 other identifier: 11077
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Dosage of NKs activity after surgery

  Dosage of NKs activity after surgery

  compare the activity of NK cells on day 1 and day 3 after surgery

Secondary Outcomes (7)

• Pain scores

  pain scores 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

• Surgical complications

  Within 3 days after surgery

• Fentanyl dose

  Operative time

Study Arms (2)

Intravenous Lidocaine

EXPERIMENTAL

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

Drug: Intravenous Lidocaine

Placebo

PLACEBO COMPARATOR

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

Drug: Normal saline infusion

Interventions

Intravenous Lidocaine DRUG

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

Also known as: Chlorydrate de Lidocaine 2%

Intravenous Lidocaine

Normal saline infusion DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Hôpital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Louis-Philippe Fortier, M.D.

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

louis-Philippe Fortier, M.D.

CONTACT

1 514 252 3400; fortierlp@mac.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: April 26, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 26, 2013

Record last verified: 2012-01

Locations

CA (1)