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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05010148
Phase
PHASE3
Status
Recruiting
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Conditions

  • Postoperative Delirium
  • Postoperative Pain
  • Spinal Fusion

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lidocaine IV — DRUG
    Intravenous lidocaine will be given at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery
  • Placebo — DRUG
    D5 water given at an equivalent ml/hr as intravenous lidocaine (treatment arm) for 48 hours following major spinal surgery

Study Details

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.

Key Dates

Start date
Sep 17, 2021
Status verified
May 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
278 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Patients will be administered D5 water intravenously at the same infusion rate (ml/hr) as the intervention group for 48 hours after major spinal surgery.
  • Experimental: Intervention-Intravenous Lidocaine Infusion
    Will be administered intravenous lidocaine at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery.

Primary Outcome Measure

Incidence of Postoperative Delirium [ Time Frame: From 24 hours after start of lidocaine infusion to 3 days after surgery. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Marc Buren, MD
[email protected]
415-514-3781

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By research site
University of California, San Francisco· San Francisco, CA

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