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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Elective spinal fusion surgery

• Estimated length of stay ≥3 days

• Fluent in English

Exclusion Criteria:

Surgical:

• 2-stage spine surgery i.e. anterior-posterior on separate days*

• 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