Evaluation of Spine Surgery Analgesic Pathway: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 2
- 主要终点
- Quality of Recovery
研究概览
简要总结
Investigators plan to study the role of spine surgery analgesic pathways - for procedures with high risk of postoperative pain - in improving the quality of recovery
详细描述
This is a randomized controlled trial comparing "spine surgery analgesic pathway" with "usual care" in improving postoperative quality of recovery and pain management in spine surgery patients. At the time of surgery office visit or at the time of preoperative assessment by anesthesia care team, risk factor for suboptimal pain management will be identified and documented. Patients will be assessed at the time for surgical office visit for their risk for severe post-operative pain. Patients with 2 or more risk factors will be classified as high-risk for severe postoperative pain and the patients with less than 2 factors as low risk. After obtaining informed consent spine surgery patients will be randomized 1:1 in one of the 2 study groups on the day of the surgery:
- "Usual care" group A
- "Care pathway" group B
If the participant is randomized to the "spine surgery analgesic pathway" group the participant will be evaluated by the Acute Pain Management Service (APMS) before the surgery for their specific pain management needs. The participant will also get some additional medication for pain in preoperative and intraoperative period. Before surgery the participant will receive Acetaminophen and Gabapentin pills. During the surgery, once the participant is asleep the participant will receive an infusion of ketamine and lidocaine through the participant venous line. After the surgery the participant will receive pain medications as per current standard protocol including acetaminophen and gabapentin. Pain management team specialist will follow for pain control after a surgery as needed.
If the participant is randomized to the "usual care" group the participant will be given placebo preoperatively; the rest of the time pain medication will be provided in a routine manner as per the anesthesia care team and the surgical team. Pain management team specialist will follow for pain control after a surgery as needed.
The primary outcome will be assessed on post-operative day 3: The participants will complete a short survey about quality of recovery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years old at time of surgery - Adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patients.
- •Posterior spine surgery
- •Surgery performed at Cleveland Clinic main campus
排除标准
- •Allergy or hypersensitivity to lidocaine, ketamine, acetaminophen, gabapentin
- •Current or recent drug abuse (within past 6 months)
- •Pregnancy
- •Immune system disease such as HIV, AIDS
- •Undergoing immunosuppressive treatment
- •Recent history of sepsis
- •Contraindications to lidocaine such as heart block and hepatic insufficiency
- •Heart failure with ejection fraction less than 30%
- •Liver dysfunction manifested with increased liver enzymes to double the normal and INR of 2 or higher
结局指标
主要结局
Quality of Recovery
时间窗: Three days after surgery
Assessment of postoperative recovery should be multidimensional including physiological parameters, functional recovery parameters, and patient-reported outcomes. Quality of postoperative recovery will be assessed by asking the patient "how have you been feeling during the past 24 hours." Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery.
次要结局
- Opioid-related Side Effects Score POD1 (Postoperative Day 1)(POD1)
- Opioid-related Side Effects Score POD2 (Postoperative Day 2)(POD2)
- Opioid Utilization(up to 48 hours)
- Time-weighted Pain Score(15-min interval after surgery until postoperative 2 days or discharge, whichever came first)
研究者
Kamal Maheshwari, MD MPH
Principal Investigator
The Cleveland Clinic