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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Postoperative Delirium, Postoperative Pain, Spinal Fusion

In brief

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.

Key facts

Study ID

NCT05010148

Run by

University of California, San Francisco

People needed

278

Starts

2021-09-17

Expected to finish

2027-09-01

Last updated by the study team

2025-05-07

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Elective spinal fusion surgery
• Estimated length of stay ≥3 days
• Fluent in English

You may not qualify if…

• 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 from consenting or answering questions
• Evidence of preoperative delirium
• Participated in Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain (GIPP) or Postoperative Cognition in Older Adult Surgical Patients (PCD) study previously
• Participating in any other clinical trial

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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