The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study.

BACKGROUND

Anesthetic agents are mandatory in colorectal cancer patients undergoing surgery. Studies published so far have shown that anesthetic drugs and intervention may have different impacts on patient's outcome. Among these drugs, propofol and, more recently, local anesthetics have been mostly targeted.

METHODS/DESIGN: This study will be a prospective randomized control trial aiming to include 400 patients scheduled for curative colorectal surgery. Patients will be randomized to have general anesthesia with propofol or with sevoflurane. Each study group will be further divided into 2 subgroups of patients, of which one will receive intravenous lidocaine perioperatively. The primary outcome is to compare the incidence of cancer recurrence and survival after propofol versus sevoflurane anesthesia added or not intravenous lidocaine. Secondary outcomes will include the severity of postoperative pain, resumption of bowel function, morphine consumption, length of hospital stay, postoperative chronic pain, and rate of postoperative complications.

DISCUSSION

To our knowledge, this is the first randomized control trial registered on ClinicalTrials.gov designed to compare the effects of two different anesthetic techniques added perioperative intravenous lidocaine infusion on long-term outcomes exclusively in colorectal cancer patients undergoing surgery. The study will bring more accurate data on the effect of propofol-TIVA and perioperative iv lidocaine on the incidence of recurrences after intended curative colorectal surgery.

TRIAL REGISTRATION

Clinical Trial Registration NCT02786329 . Registered on 1 June 2016.