Actively Recruiting

Phase 3
Age: 60Years +
All Genders
Healthy Volunteers
NCT05010148

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

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Elective spinal fusion surgery
  • Estimated hospital stay of at least 3 days
  • Fluent in English
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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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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