NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery

Colorectal Cancer Clinical Trial

Official title:

NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01841294
• Other study ID #: 11077
• Status: Recruiting
• Phase: Phase 4
• First received: February 27, 2013
• Last updated: April 25, 2013
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2012
• Source: Maisonneuve-Rosemont Hospital
• Contact: louis-Philippe Fortier, M.D.
• Phone: 1 514 252 3400
• Email: fortierlp[@]mac.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve Rosemont	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain scores	From the PACU to the 3rd day after surgery	pain scores from the PACU to the 3rd day after surgery	No
Secondary	Morphine consumption	Morphine consumption from the PACU to the 3rd day after surgery	From the PACU to the 3rd day after surgery	No
Secondary	Ileus time	time to get flattus after surgery	Day 1 and Day 3 after surgery	No
Secondary	Surgical complications	Infections, leakage, abcess	Within 3 days after surgery	Yes
Secondary	Fentanyl dose	Cumulative dose of fentanyl needed for the surgery	Operative time	No
Secondary	Nausea and vomiting	Nausea and vomiting from the PACU to the 3rd day after surgery	From the PACU to the 3rd day after surgery	No
Secondary	Major adverses events	Hypotension, heart rythm blocks, tachycarida, bradycardia	Start of the surgery untill one hour after PACU ad;ission	Yes