NCT05010148 A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain
| NCT ID | NCT05010148 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of California, San Francisco |
| Condition | Postoperative Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 278 participants |
| Start Date | 2021-09-17 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 278 participants in total. It began in 2021-09-17 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Marc A Buren, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05010148 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Postoperative Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05010148 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 278 participants.
Is NCT05010148 currently recruiting?
Yes, NCT05010148 is actively recruiting participants. Contact the research team at marc.buren@ucsf.edu for enrollment information.
Where is the NCT05010148 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05010148 clinical trial?
NCT05010148 is sponsored by University of California, San Francisco. The principal investigator is Marc A Buren, MD at University of California, San Francisco. The trial plans to enroll 278 participants.