Continuous Post-operative Lidocaine Infusion Following Major Reconstructive Spine Surgery in the Elderly to Minimize Delirium and Opiate Use: A Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• Elective spinal fusion surgery

• Estimated length of stay ≥3 days

• Fluent in English

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Marc A Buren, MD
marc.buren@ucsf.edu
415-476-8369
Time Frame
Start Date: 2021-09-17
Estimated Completion Date: 2027-09
Participants
Target number of participants: 278
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov