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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: Recruiting Phase 3 study of Postoperative Pain and Spinal Fusion, sponsored by University of California, San Francisco.
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 230-participant average among 120 other Postoperative Pain trials with a reported enrollment target (21% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Confusion Assessment Method (CAM) will be performed once daily using a structured interview to assess for delirium incidence. Delirium cases will be validated by a second investigator. Investigators will collect preoperative and surgery related variables that may be associated with delirium.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lidocaine IV
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2021-09-17 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
What NCT05010148 shows while recruiting
NCT05010148 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, above the 230-participant average among 120 other Postoperative Pain trials with a reported enrollment target (21% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05010148's enrollment target sits among peer trials
278 22nd of 120 higher than 99 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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