Comparison of Combined Lumbar and Sacral Plexus Block With Sedation Versus General Endotracheal Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Hip Fracture Surgery(CLSB-HIPELD): Rationale and Design of a Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,086
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
Hip fracture is a global public health problem. The postoperative mortality and disability rate of hip fracture is high, and early surgery is still the most effective treatment method, but these patients are often associated with concurrent heart and lung and other organ dysfunction, anesthesia and surgery are extremely risky, mainly associated with high incidence of complications in the pulmonary and cardiovascular system, and anesthesia plays a vital role in ensuring that these patients can safely and effectively get through the perioperative period.
The research on the relationship between anesthetic methods and hip fracture surgery prognosis mainly focuses on comparison between neuraxial anesthesia (including spinal anesthesia and epidural anesthesia) and general anesthesia with endotracheal intubation until now. In addition to general anesthesia with endotracheal intubation and neuraxial anesthesia, ultrasound-guided lumbar plexus and sciatic nerve block has been widely used in hip fracture surgery in recent years, especially for some high-risk patients with cardiopulmonary dysfunction. However, it is not clear whether ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia can improve the prognosis of elderly patients with hip fracture, and in this study, we plan to make a prospective, multicenter, randomized controlled clinical trial to compare the effects of general anesthesia with endotracheal intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly patients with hip fracture.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 77 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥77 years old;
- •First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture;
- •Patient with planned hip fracture surgery within 24-72 h;
- •Patient without peripheral nerve block within 24 h prior to surgery;
- •The ability to receive written informed consent from the patient or patient's legal representative.
排除标准
- •Refuse to participate;
- •Unable to perform nerve block;
- •Multiple trauma, multiple fractures or other fractures outside the inclusion criteria, such as pathological fractures, pelvic fractures, femur fractures;
- •Prosthetic fracture;
- •Scheduled for bilateral hip fracture surgery;
- •Usage of bone-cement fixation in the surgery;
- •With recent cerebral stroke (<3 months);
- •Combined with active heart disease (unstable angina, acute myocardial infarction, recent myocardial infarction; decompensated heart failure; symptomatic arrhythmia; severe mitral or aortic stenotic heart disease);
- •Patient with known severe lung and/or airway disease, acute respiratory failure, acute pulmonary infection, and acute attack of bronchial asthma;
- •Current enrolment in another clinical trial;
- •Contraindication for general endotracheal anesthesia(drug allergies to general anesthesia, difficult airway);
- •Contraindication for lumbar and sacral plexus block(infection at the site of needle insertion, coagulopathy, allergy to local anesthetics).
结局指标
主要结局
mortality
时间窗: month 12
Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.
次要结局
- Incidence of various complications and comprehensive complication index during hospitalization after surgery(up to 8 weeks after the surgery)
- the Confusion Assessment Method(CAM)(within 3 days after surgery)
- Duration of surgery(from the start to the end of the surgery)
- Length of stay in ICU and hospital(up to 8 weeks after the surgery)
- High-sensitivity cardiac troponin T(hs-cTnT)(1 day before surgery,1 and 3 days after surgery)
- MMSE(Mini-mental State Examination)(within 3 days after surgery)
- Intraoperative complications(Intraoperative)
- SOFA score(sequential organ failure assessment score)(within 3 days after surgery)
研究者
Xiaofeng WANG
Attending doctor
Shanghai 6th People's Hospital