A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 10, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called intravenous lidocaine can help prevent delirium and reduce pain after spinal surgery. Delirium is a common problem that can happen after surgery, leading to confusion and other cognitive issues. Researchers believe that better pain control might reduce the chances of developing delirium. By using lidocaine, which has shown promise in managing pain in other situations, the study aims to see if it can improve recovery for patients undergoing major spinal fusion surgery.

To participate in this trial, individuals must be scheduled for elective spinal fusion surgery and expect to stay in the hospital for at least three days. They should also be fluent in English. However, there are certain criteria that might exclude someone, such as having significant heart problems, allergies to lidocaine, or severe cognitive impairment. Participants in the trial can expect to receive the lidocaine treatment after their surgery and be monitored for any effects on their pain levels and the occurrence of delirium. This study is currently recruiting participants, and being part of it could contribute to finding better ways to help patients recover after spinal surgery.

Gender

ALL

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