A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of California, San Francisco
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Elective spinal fusion surgery
Estimated length of stay ≥3 days
Fluent in English
Disqualifiers
Cervical spine surgery
Non-spine surgeries
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine IV
DrugIntravenous lidocaine will be given at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery
Placebo
DrugD5 water given at an equivalent ml/hr as intravenous lidocaine (treatment arm) for 48 hours following major spinal surgery
Treatment groups
278 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Intervention-Intravenous Lidocaine InfusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Postoperative Delirium
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.
Time frame
From 24 hours after start of lidocaine infusion to 3 days after surgery.Secondary outcomes
1
Severity of Postoperative Delirium
To rate delirium severity, the Memorial Delirium Assessment Scale (MDAS) will be used.
Time frame
From 24 hours after start of lidocaine infusion to 3 days after surgery.2
Postoperative Opioid Use
Postoperative opioids will be measured and abstracted from the electronic medical record. The investigators will convert all opioids to oral morphine equivalents.
Time frame
From 24 hours after start of lidocaine infusion to discharge, up to one week.3
Difference in Postoperative Pain Scores Between Treatment Groups
Pain will be measured every 8 hours using the 11-point visual analog scale (1=no pain and 10=the worst pain possible) both at rest and with movement preoperatively and daily postoperatively during the hospital admission. In addition, the site and treatment of pain, and the maximal level of pain experienced postoperatively will be measured.
Time frame
From 8 hours after start of lidocaine infusion to discharge, up to one week.4
Difference in Analgesic Satisfaction Scores Between Treatment Groups
Analgesic satisfaction will be measured daily postoperatively during the hospital admission using the 10-point visual analog scale (1=least satisfied and 10=most satisfied). Patients will be asked daily about the quality of their analgesic regimen and will be asked at their first postoperative follow up appointment with their surgeon.
Time frame
From 24 hours after start of lidocaine infusion to 3 days after surgery.Sponsors and contacts
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Source ClinicalTrials.gov