Continuous Post-operative Lidocaine Infusion Following Major Reconstructive Spine Surgery in the Elderly to Minimize Delirium and Opiate Use: A Randomized Control Trial

What this Trial Is About

Researchers are studying whether a continuous intravenous lidocaine infusion after major reconstructive spinal surgery can reduce the risk and severity of postoperative delirium and lessen opioid-related side effects in elderly patients. Postoperative delirium is common after non-cardiac surgery and linked to poor outcomes, with poor pain control being a modifiable risk factor. This study is a randomized, double-blinded, placebo-controlled trial involving 60 patients undergoing major elective spine surgery involving more than three levels of instrumentation and fusion. Participants will be randomly assigned to receive either a lidocaine infusion at 1.33 mg/kg/hr based on adjusted body weight or a placebo (D5 water) intravenously for 48 hours following surgery. Anesthetic management during surgery is standardized with total intravenous anesthesia including propofol, lidocaine, magnesium, fentanyl, and sevoflurane. The lidocaine infusion or placebo begins postoperatively before discharge from the post-anesthetic care unit or upon intensive care unit arrival. During the study, participants will be monitored for the incidence and severity of postoperative delirium from 24 hours after starting the infusion to 3 days post-surgery. Researchers will also assess opioid use, pain scores, opioid-related side effects, analgesic satisfaction, functional recovery using surveys and physical therapy participation, time to discharge, and cognitive function up to 3 months. Safety and tolerability of lidocaine will be closely observed, with continuous monitoring during and after surgery. The total follow-up includes assessments up to hospital discharge and longer-term functional outcomes at 3 months.

A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain