Actively Recruiting
A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain
Led by University of California, San Francisco · Updated on 2025-05-07
278
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elective spinal fusion surgery
- Estimated hospital stay of at least 3 days
- Fluent in English
You will not qualify if you...
- Cervical spine surgery
- Non-spine surgeries
- Allergy or intolerance to lidocaine
- Significant heart disease including 2nd or 3rd degree heart block without pacemaker, low heart function (LVEF <30%), or certain arrhythmias
- Significant liver or kidney dysfunction
- History of uncontrolled seizures
- Acute porphyria
- Preoperative use of long-acting opioids or opioid use equal to or greater than 60 mg oral morphine equivalents
- Severe cognitive impairment (SPMSQ score >5 or reported by proxy)
- Physical impairment preventing consent or answering questions
- Evidence of preoperative delirium
- Previous participation in specific delirium and pain clinical trials
- Participation in any other clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
M
Marc A Buren, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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