Recruiting
Phase 3

Lidocaine

Sponsor:

UCLA

Code:

NCT05010148

Conditions

Postoperative Delirium

Postoperative Pain

Spinal Fusion

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Lidocaine IV

Placebo

Study Details

Brief 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

Study ID

NCT05010148

Start date

Sep 17, 2021

Status verified date

May, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

278 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Lidocaine IV

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

Placebo

D5 water given at an equivalent ml/hr as intravenous lidocaine (treatment arm) 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 and Locations

Central contacts

Marc A Buren, MD

415-476-8369marc.buren@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Marc Buren, MD

415-514-3781marc.buren@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

May 7, 2025

Last verified

May, 2025

Keywords

  • lidocaine
  • spinal surgery
  • opioid sparing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-05-07.