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NCT05010148 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Postoperative Pain and Spinal Fusion, sponsored by University of California, San Francisco.

Recruiting
Registry status
Phase 3
Development phase
278
Enrollment target
1
Study location

NCT05010148 is a Phase 3 study of Postoperative Pain and Spinal Fusion that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 278 participants, above the 227-participant average among 63 other Postoperative Pain trials with a reported enrollment target (22% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05010148, a Phase 3 study of Postoperative Pain and Spinal Fusion, is actively recruiting participants, sponsored by University of California, San Francisco.

RECRUITING
Registry status
Phase 3
Development phase
278 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Lidocaine IV

Study Locations (1)

California

  • University of California, San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 278 participants
Start Date 2021-09-17
Est. Completion 2027-09
Phase Phase 3

What the Registry Record Tells You About NCT05010148

The ClinicalTrials.gov registry entry for NCT05010148 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 278 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 227-participant average among 63 other Postoperative Pain trials with a reported enrollment target (22% higher). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05010148 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05010148 about?

NCT05010148 is a clinical study titled "A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain". 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 intervent...

What is the current status of trial NCT05010148?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 278 participants. The study started on 2021-09-17. Estimated completion is 2027-09.

What conditions does trial NCT05010148 study?

This clinical trial studies the following conditions: Postoperative Pain, Spinal Fusion, Postoperative Delirium.

What interventions are being tested in trial NCT05010148?

The interventions under investigation include: Placebo (DRUG), Lidocaine IV (DRUG).

Who is sponsoring clinical trial NCT05010148?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05010148 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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