NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery
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|ClinicalTrials.gov Identifier: NCT01841294|
Recruitment Status : Unknown
Verified January 2012 by Louis-Philippe Fortier, Maisonneuve-Rosemont Hospital.
Recruitment status was: Recruiting
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Intravenous Lidocaine Drug: Normal saline infusion||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Basic Science|
|Official Title:||NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
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
Drug: Intravenous Lidocaine
Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
Other Name: Chlorydrate de Lidocaine 2%
Placebo Comparator: Placebo
Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission
Drug: Normal saline infusion
Normal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
- Dosage of NKs activity after surgery [ Time Frame: compare the activity of NK cells on day 1 and day 3 after surgery ]Dosage of NKs activity after surgery
- Pain scores [ Time Frame: pain scores from the PACU to the 3rd day after surgery ]From the PACU to the 3rd day after surgery
- Morphine consumption [ Time Frame: From the PACU to the 3rd day after surgery ]Morphine consumption from the PACU to the 3rd day after surgery
- Ileus time [ Time Frame: Day 1 and Day 3 after surgery ]time to get flattus after surgery
- Surgical complications [ Time Frame: Within 3 days after surgery ]Infections, leakage, abcess
- Fentanyl dose [ Time Frame: Operative time ]Cumulative dose of fentanyl needed for the surgery
- Nausea and vomiting [ Time Frame: From the PACU to the 3rd day after surgery ]Nausea and vomiting from the PACU to the 3rd day after surgery
- Major adverses events [ Time Frame: Start of the surgery untill one hour after PACU ad;ission ]Hypotension, heart rythm blocks, tachycarida, bradycardia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841294
|Contact: louis-Philippe Fortier, M.D.||1 514 252 firstname.lastname@example.org|
|Hôpital Maisonneuve Rosemont||Recruiting|
|Montreal, Quebec, Canada, H1T 2M4|
|Contact: Nadia godin 1 514 252 3400 ext 3153 email@example.com|
|Principal Investigator:||Louis-Philippe Fortier, M.D.||Hôpital Maisonneuve Rosemont|