A Phase 4 interventional study of Intravenous Lidocaine and Normal saline infusion in Colorectal Cancer, sponsored by Maisonneuve-Rosemont Hospital. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-04-26.
Sponsored by Maisonneuve-Rosemont Hospital · Phase 4, Interventional, and Basic science
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 50 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Maisonneuve-Rosemont Hospital is the lead sponsor of 70 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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
Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission
Drug: Normal saline infusion
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%
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
Dosage of NKs activity after surgery
Time frame: compare the activity of NK cells on day 1 and day 3 after surgery
Pain scores
From the PACU to the 3rd day after surgery
Time frame: pain scores from the PACU to the 3rd day after surgery
Morphine consumption
Morphine consumption from the PACU to the 3rd day after surgery
Time frame: From the PACU to the 3rd day after surgery
Ileus time
time to get flattus after surgery
Time frame: Day 1 and Day 3 after surgery
Surgical complications
Infections, leakage, abcess
Time frame: Within 3 days after surgery
Fentanyl dose
Cumulative dose of fentanyl needed for the surgery
Time frame: Operative time
Nausea and vomiting
Nausea and vomiting from the PACU to the 3rd day after surgery
Time frame: From the PACU to the 3rd day after surgery
Major adverses events
Hypotension, heart rythm blocks, tachycarida, bradycardia
Time frame: Start of the surgery untill one hour after PACU ad;ission
This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Maisonneuve-Rosemont Hospital