Can a common anesthetic stop Post-Surgery delirium in the elderly?
NCT ID NCT05010148
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Older adults who have major reconstructive spine surgery often develop postoperative delirium, a sudden state of confusion that can lead to longer hospital stays and lasting cognitive problems. Poor pain control raises that risk, and opioids used for pain bring their own side effects. This Phase 3 trial tests whether a continuous intravenous infusion of lidocaine, a widely used local anesthetic, given for 48 hours after surgery can lower the chance of delirium and reduce the amount of opioids patients need. The study enrolls adults scheduled for elective spinal fusion with an expected hospital stay of at least three days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lidocaine, a common local anesthetic given as an intravenous infusion
- What this could lead to
- If it works, a 48-hour lidocaine drip could become a standard way to protect older adults from confusion and heavy opioid use after major spine surgery.
- What could go wrong
- Lidocaine can cause heart rhythm problems, so people with significant heart disease cannot join. The infusion may fail to prevent delirium, and the results may not apply to other types of surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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219 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Jan 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of California, San Francisco
San Francisco, California, 94143, United States
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