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Recruiting Phase 3 NCT05010148

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

◆ AI Clinical Summary

This study tests whether an intravenous lidocaine infusion given after spine surgery can help prevent delirium (confusion and disorientation) and reduce pain during recovery. Delirium is a common complication after surgery that can affect memory and overall health outcomes.

Key Objective: The trial is testing whether intravenous lidocaine can prevent post-operative delirium and reduce pain following spinal surgery.

Who to Consider: Adults scheduled for elective spinal surgery who are interested in potentially reducing their risk of post-operative confusion and pain should consider enrolling.

Trial Parameters

Condition Postoperative Delirium
Sponsor University of California, San Francisco
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 278
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2021-09-17
Completion 2027-09
Interventions
Lidocaine IVPlacebo

Brief Summary

Postoperative delirium is one of the most frequent adverse events following elective non-cardiac surgery and is associated with cognitive impairment at discharge, as well as in-hospital and long-term mortality, however, despite being a well-recognized problem there is a dearth of effective interventions for prevention and management. A modifiable risk factor associated with postoperative delirium is poor postoperative pain control, and by improving the pain regimen the investigators may be able to decrease the incidence and/or severity of postoperative delirium. In this study, the investigators seek to study whether a postoperative intravenous infusion of lidocaine, known to improve pain control in other contexts, can decrease the risk of postoperative delirium and other opioid-related side effects, following major reconstructive spinal surgery.

Eligibility Criteria

Inclusion Criteria: * Elective spinal fusion surgery * Estimated length of stay ≥3 days * Fluent in English Exclusion Criteria: Surgical: * Cervical spine surgery * Non-spine surgeries Other: * Allergy or intolerance of lidocaine * Significant heart disease (2nd or 3rd heart block without a pacemaker, Left ventricular ejection fraction (LVEF) \<30%, significant arrhythmia \[Adams-strokes, Wolff-Parkinson-white syndrome\], concurrent treatment with a class 1 antiarrhythmic or amiodarone) * Significant hepatic or renal dysfunction * History of uncontrolled seizures * Acute porphyria * Preoperative usage of long-acting opioids (methadone, buprenorphine, fentanyl patch, ms-contin, oxycontin) or preoperative opioid usage greater than or equal to the equivalent of 60 mg of oral morphine equivalents. * Severe cognitive impairment (reported by proxy or a score of \>5 on the Short Portable Mental Status Questionnaire (SPMSQ)) * Self-, or proxy-reported physical impairment preventing the subject

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