A Clinical Trial of 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
University of California, San Francisco
278 participants
Sep 17, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Elective spinal fusion surgery
- Estimated length of stay ≥3 days
- Fluent in English
Exclusion Criteria15
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Intravenous lidocaine will be given at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery
D5 water given at an equivalent ml/hr as intravenous lidocaine (treatment arm) for 48 hours following major spinal surgery
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05010148