Can a common anesthetic stop Post-Surgery delirium in the elderly?

NCT ID NCT05010148

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

219 people

The number who actually took part.

Started

Sep 2021

Finished

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

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

delirium Emergence Delirium Pain, Postoperative

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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