Intrathecal Morphine for Postoperative Analgesia in Video-Assisted and Robotic-Assisted Thoracic Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative morphine equivalent consumption
研究概览
简要总结
VATS/RATS is widely used for diagnosis and treatment of intrathoracic conditions. Despite many benefits, postoperative pain continues to be intense after VATS/RATS. The optimal strategy for pain management has not been defined. In this randomized, placebo-controlled, double-blinded clinical investigation, investigators hypothesize that 5 mcg/kg intrathecal morphine will decrease postoperative analgesic consumption and reduce pain.
详细描述
This is a randomized, placebo-controlled, double-blinded clinical trial. Patients will be randomized into one of two groups. Group A (Placebo, control group) will receive intrathecal sterile normal saline and Group B (Morphine group) will receive 5mcg/kg preservative free intrathecal morphine.
American Pain Society Outcome Questionnaire (APS-POQ) will be administered to patients prior to discharge (see data sheet).
Patients will be followed up with a phone survey at 1 and 3 months after surgery to assess the presence, nature, and severity of chronic persistent surgical pain. The Brief Pain Inventory is a reliable and valid measures of the interference of pain with physical functioning and will be used. Additionally patients will be asked about use of pain medications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Age 18-80 years old
- •Undergoing elective video-assisted thoracoscopic or robotic assisted surgery for anatomical lung resection
- •General anesthesia with anticipated intraoperative extubation.
排除标准
- •American Society of Anesthesiologists (ASA) classification of 4 or 5
- •Anticipated postoperative intubation
- •Significant liver disease
- •Preoperative use of intravenous inotropes and/or vasopressor support
- •Preoperative mechanical ventilation
- •Preoperative use of mechanical circulatory support device (intraaortic balloon pump, ventricular assist device, extracorporeal membrane oxygenation)
- •Severe pulmonary disease (home oxygen requirement and/or current oral steroid use)
- •Morphine allergy
- •Opioid or alcohol abuse
- •Chronic pain
- •Renal failure
- •Inability to comprehend English language
- •Bleeding disorder
- •Abnormal preoperative coagulation
- •Infection
- •Patient refusal
- •Failed spinal
研究组 & 干预措施
Placebo
Placebo, Intrathecal saline
干预措施: Placebo (Other)
Morphine
Intrathecal morphine
干预措施: Morphine Sulfate (Drug)
结局指标
主要结局
Postoperative morphine equivalent consumption
时间窗: 24 hours after surgery
Total MG of analgesic medications given converted to morphine
次要结局
- pain qualities(1 month and 3 months after surgery)
- Self-reported patient satisfaction(prior to discharge from hospital, likely 1-3 days after surgery)
- Self reported use of analgesic medications(1 month and 3 months after surgery)
- self-reported limitation of daily activity at 1 and 3 months(1 month and 3 months after surgery)
- Number of pain interventions(up to 48 hours postoperative)
- Postoperative opioid related side effects(up to 48 hours postoperative)
- Postoperative pain(Up to 48 hours postoperative)
研究者
Richa Dhawan
Associate Professor
Northwestern University