Abstract
BackgroundPain after major head and neck cancer surgery is underestimated and has both nociceptive and neuropathic characteristics. Extended resection, flap coverage, nerve lesions, inflammation, and high-dose opioid administration can also lead to hyperalgesia and chronic postoperative pain. Opioids are frequently associated with adverse events such as dizziness, drowsiness, nausea and vomiting, or constipation disturbing postoperative recovery and extending the length of hospital stay. Patients eligible for major head and neck cancer surgery cannot benefit from full multimodal pain management with locoregional anesthesia. Intravenous lidocaine, investigated in several studies, has been found to decrease acute pain and morphine consumption. Some data suggest also that it can prevent chronic postsurgical pain. Evidence supporting its use varies between surgical procedures, and there is no published study regarding systemic lidocaine administration in major head and neck cancer surgery. We hypothesized that intravenous lidocaine infused in the perioperative period would lead to opioid sparing and chronic postsurgical pain reduction.Methods/designA total of 128 patients undergoing major head and neck surgery will be included in this prospective two-center, double-blind, randomized controlled trial. Patients will be randomly assigned to lidocaine or placebo treatment. After induction of general anesthesia, an intravenous lidocaine bolus will be administered (1.5 mg.kg− 1), followed by a continuous infusion (2 mg.kg− 1.h− 1) which will be reduced in the postanesthesia care unit (1 mg.kg− 1.h− 1). The primary outcome measure is morphine consumption 48 h after surgery. The secondary outcomes include intraoperative remifentanil consumption, morphine consumption 24 h after surgery, and chronic postsurgical pain that will be assessed 3–6 months after surgery.DiscussionRecent evidence suggests that intravenous lidocaine can lead to opioid sparing and chronic postsurgical pain reduction for certain types of surgery. This is the first trial to prospectively investigate the efficacy and safety of intravenous lidocaine in major head and neck cancer surgery.Trial registrationClinicalTrials.gov, NCT02894710. Registered on 11 August 2016.
Highlights
Pain after major head and neck cancer surgery is underestimated and has both nociceptive and neuropathic characteristics
Recent evidence suggests that intravenous lidocaine can lead to opioid sparing and chronic postsurgical pain reduction for certain types of surgery
A recent meta-analysis found that the efficacy of perioperative intravenous lidocaine for postoperative pain varies between surgical procedures [8]
Summary
Benefits Recently, intravenous lidocaine has been shown to effectively control postoperative pain according to the surgical procedure. Lidocaine is widely used intravenously in the perioperative period for abdominal and urological procedures and could lead to opioid sparing, through analgesic and anti-inflammatory properties [8]. Surgical techniques will be obviously different according to each procedure, and we have planned subgroup analyses (with or without major pectoralis flap or free flap). Another limitation is that, for organizational issues, treatment units have to be prepared by a PACU nurse who brings the syringe to the operating theater but who will not be involved in the care of the study patient.
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