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

NCT05010148 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2025-05-07

No results posted yet for this 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.

Conditions

  • Postoperative Delirium
  • Postoperative Pain
  • Spinal Fusion

Interventions

DRUG

Lidocaine IV

Intravenous lidocaine will be given at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery

DRUG

Placebo

D5 water given at an equivalent ml/hr as intravenous lidocaine (treatment arm) for 48 hours following major spinal surgery

Sponsors & Collaborators

Principal Investigators

  • Marc A Buren, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05010148 on ClinicalTrials.gov