Using intravenous lidocaine after spinal surgery to prevent delirium and reduce pain
Continuous Post-operative Lidocaine Infusion Following Major Reconstructive Spine Surgery in the Elderly to Minimize Delirium and Opiate Use: A Randomized Control Trial
This study tests if giving lidocaine through an IV after spinal surgery can help reduce pain and prevent confusion in patients.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 278 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05010148 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of intravenous lidocaine on postoperative delirium and pain management in patients undergoing major elective spinal fusion surgery. It is a randomized, double-blinded, placebo-controlled trial involving 60 patients, aiming to determine if lidocaine can improve pain control and reduce the incidence of delirium. The study standardizes the anesthetic regimen and includes specific inclusion and exclusion criteria to ensure patient safety and relevance. The goal is to provide a potential intervention for a common postoperative complication.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing elective spinal fusion surgery with an expected hospital stay of three days or more.
Not a fit: Patients with significant heart disease, severe cognitive impairment, or those undergoing cervical spine surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium and improve pain management for patients undergoing spinal surgery.
How similar studies have performed: While the use of lidocaine for pain management is established, this specific application for preventing postoperative delirium in spinal surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Marc A Buren, MD — University of California, San Francisco
- Study coordinator: Marc A Buren, MD
- Email: marc.buren@ucsf.edu
- Phone: 415-476-8369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.