Continuous Post-operative Lidocaine Infusion Following Major Reconstructive Spine Surgery in the Elderly to Minimize Delirium and Opiate Use: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Delirium
研究概览
简要总结
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.
详细描述
Methods:
The investigators will perform a pilot prospective randomized double-blinded placebo-controlled trial of 60 patients undergoing major elective reconstructive spinal surgery to investigate the effect of a postoperative lidocaine infusion on the incidence and severity of postoperative delirium. Major spine surgery is defined as posterior spine fusions >3 levels of instrumentation and fusion, which allows standardization of the level of surgical insult and postoperative analgesic requirements. The intraoperative anesthetic regimen will be standardized to consist of total intravenous anesthesia using sevoflurane, propofol, lidocaine and magnesium (institutional protocol), and fentanyl with boluses allowed per provider discretion.
Patient recruitment, inclusion and exclusion criteria: All surgeons will be contacted before the start of the study to obtain their consent to allow their patients to be studied. The research team has successfully completed multiple National Institutes of Health (NIH) funded cohort and clinical trials at our institution with no surgeon refusing to participate. Eligible patients will be screened from the operating room roster to determine their eligibility. Patients will be contacted by phone or in person for preoperative evaluation. Please see the other section for inclusion and exclusion criteria.
Sample Size Calculation:
The recruitment will be consecutive patients meeting inclusion criteria. Reductions in opioid consumption by ~25% using intravenous lidocaine infusions have been shown to decrease opioid related side effects, but there is essentially no data linking a specific degree of opioid reduction to effects on delirium (46, 47). The most comparable published study to the investigators' proposal is work done by Kaba (2009) studying a lidocaine infusion for abdominal surgery where the average opioid reduction was ~50% (24mg +/-16.3 of piritramide in the placebo vs. 10.33mg +/- 10.33 in the treatment group). Assuming similar reduction in opioids of 50% and similar variance, the proposed sample size, 60 (30 per group), provides a power of 0.8 (alpha = 0.05) to detect a 25% decrease in the use of postoperative opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective spinal fusion surgery
- •Estimated length of stay ≥3 days
- •Fluent in English
排除标准
- •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)
- •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
研究组 & 干预措施
Intervention-Intravenous Lidocaine Infusion
Will be administered intravenous lidocaine at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery.
干预措施: Lidocaine IV (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Postoperative Delirium
时间窗: From 24 hours after start of lidocaine infusion to 3 days after surgery.
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.
次要结局
- Difference in Opioid Related Side Effects Between Treatment Groups: Pruritus-Investigator Assessment(From 4 hours after start of lidocaine infusion to discharge, up to one week.)
- Difference in Ability to Participate in Physical Therapy Between Treatment Groups(From 24 hours after start of lidocaine infusion to 3 days after surgery.)
- Word List Learning (Cognition)(From 24 hours after start of lidocaine infusion to 3 days after surgery.)
- Difference in Postoperative Pain Scores Between Treatment Groups(From 8 hours after start of lidocaine infusion to discharge, up to one week.)
- Difference in Analgesic Satisfaction Scores Between Treatment Groups(From 24 hours after start of lidocaine infusion to 3 days after surgery.)
- Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Respiratory Rate(From 4 hours after start of lidocaine infusion to discharge, up to one week.)
- Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Saturated Pulse Oximetry(From 4 hours after start of lidocaine infusion to discharge, up to one week.)
- Difference in Opioid Related Side Effects Between Treatment Groups: Sedation(From 4 hours after start of lidocaine infusion to discharge, up to one week.)
- Difference in Lidocaine Related Adverse Events Between Treatment Groups(From 4 hours after the start of the lidocaine infusion up to 72 hours.)
- Difference in Associative Learning Between Treatment Groups (Cognition)(From 24 hours after start of lidocaine infusion to 3 days after surgery.)
- Severity of Postoperative Delirium(From 24 hours after start of lidocaine infusion to 3 days after surgery.)
- Difference in Opioid Related Side Effects Between Treatment Groups: Nausea, Vomiting, Constipation-Investigator Assessments(From 4 hours after start of lidocaine infusion to discharge, up to one week.)
- Difference in Functional Outcome Between Treatment Groups Using Short Form 36 (SF-36)(Baseline and 3 months.)
- Difference in Functional Outcome Between Treatment Groups Using Oswestry Disability Index (ODI)(Baseline and 3 months.)
- Postoperative Opioid Use(From 24 hours after start of lidocaine infusion to discharge, up to one week.)
- Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Naloxone Administration(From 4 hours after start of lidocaine infusion to discharge, up to one week.)
- Difference in Time to Discharge Between Treatment Groups(End of hospitalization, at time of discharge, approximately 1 week.)
- Difference in Cognitive Functioning Between Treatment Groups(From 24 hours after start of lidocaine infusion to 3 days after surgery.)
- Cognitive Status(From 24 hours after start of lidocaine infusion to 3 days after surgery.)
- Difference in Verbal Fluency Between Treatment Groups (Cognition)(From 24 hours after start of lidocaine infusion to 3 days after surgery.)
- Difference in Opioid Related Side Effects Between Treatment Groups: Nausea, Vomiting, Constipation-Anti-Emetic Administration(From 4 hours after start of lidocaine infusion to discharge, up to one week.)