Status:
RECRUITING
A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain
Lead Sponsor:
University of California, San Francisco
Conditions:
Postoperative Delirium
Postoperative Pain
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Methods: The investigators will perform a pilot prospective randomized double-blinded placebo-controlled trial of 60 patients undergoing major elective reconstructive spinal surgery to investigate th...
Eligibility 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
Key Trial Info
Start Date :
September 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT05010148
Start Date
September 17 2021
End Date
September 1 2027
Last Update
May 7 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143