Intravenous Lidocaine in Carcinologic ENT Surgery: A Randomized Controlled Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain (ELICO)

NCT02894710 Phase 3 COMPLETED

Lidocaine, local anesthetic used for more than five decades, is being intravenously administered aiming at managing pain in different types of surgeries with promising results. Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to the difficulty of locoregional anesthesia and high level of opioid consumption. This randomized study aims to compare quality of perioperative analgesia after infusion of intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is to evaluate morphine consumption during the 48 postoperative hours. Others purposes are evaluation of peroperative remifentanil consumption, morphine consumption during the 24 postoperative hours, chronic post-surgical pain evaluated from 3 to 6 months after carcinologic ENT surgery, and incidence of side effects that can be attributed to lidocaine infusion.

Details

Lead sponsor	Hospices Civils de Lyon
Phase	Phase 3
Status	COMPLETED
Enrolment	143
Start date	2016-12
Completion	2019-12

Conditions

• Carcinologic Ear, Nose, and Throat (ENT) Surgery

Interventions

• Lidocaine 20mg/ml
• Glucose 5% (placebo)

Primary outcomes

• Total morphine requirement during the first 48 postoperative hours — 48 postoperative hours (H48)
  Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour.

Countries

France