Effect of intravenous lidocaine on pain after head and neck cancer surgery (ELICO trial): A randomised controlled trial

Background: Treatment of postoperative pain after ear, nose and throat (ENT) cancer surgery is mainly morphine administration. Additional systemic lidocaine has shown promising results in some surgical procedures.

Objective: The main objective was to evaluate morphine consumption in the first 48 postoperative hours after intra-operative lidocaine infusion during major ENT cancer surgery.

Design: A randomised, double-blind, placebo-controlled trial.

Setting: Bicentric study including a university hospital and a major cancer centre, conducted from December 2016 to December 2019.

Patients: A total of 144 patients undergoing major ENT cancer surgery were included.

Intervention: The patients were randomly assigned to receive intravenous lidocaine or placebo during surgery and in the recovery room.

Main outcome measures: Endpoints were postoperative morphine consumption in the first 24 and 48 h postoperatively, intra-operative remifentanil consumption, adverse events occurrence and assessment 3 to 6 months after surgery with the McGill pain questionnaire.

Results: A total of 118 patients were included (lidocaine n = 57; placebo n = 61, 26 patients were excluded). There was no significant difference in morphine consumption during the first 48 postoperative hours in the lidocaine group compared with the placebo group with a median [IQR] of 0.60 [0.30 to 1.03] mg kg -1 vs. 0.57 [0.37 to 0.96] mg kg -1 , total dose 44 [21 to 73.3] mg vs. 38 [23.3 to 56.5] mg, P = 0.92.There was no significant difference between the two groups in any of the other endpoints, including at follow up 3 to 6 months after surgery.

Conclusion: Intravenous lidocaine in ENT cancer surgery did not show any additional analgesic or morphine-sparing effect 48 h after surgery. Three to six months after surgery, there was no significant difference in pain scores or consumption of analgesics. Patients treated pre-operatively with opioids were not evaluated in the study.

Trial registration: Clinicaltrials.gov identifier: NCT02894710 and EUDRACT number 2015-005799-90.