The Effect of Bupivacaine Liposome Preemptive Analgesia on Postoperative Pain and Delirium in Elderly Patients Undergoing Hip Fracture Surgery: A Randomized, Parallel Controlled Prospective Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- POD incidence
研究概览
简要总结
To explore the effects of bupivacaine liposomes in preemptive analgesia for iliofascial block on postoperative pain and postoperative delirium in elderly patients with hip fractures, to optimize perioperative analgesia strategies, to reduce the incidence of postoperative delirium, and to improve patient prognosis.
详细描述
The incidence of hip fractures has risen significantly with population aging. In 2016, the incidence of hip fractures in China was 177 per 100,000 for women and 99 per 100,000 for men, and it is projected that the number of hip fracture surgeries worldwide will reach 6.3 million by 2050. Surgical treatment is preferred among elderly hip fracture patients, but postoperative delirium (POD) is a common complication, with an incidence rate of 4.0%-53.3%, which is much higher than that of elective surgery patients (3.6%-28.3%). POD is closely associated with increased morbidity, mortality and medical expenses, and its mechanism is complex, involving sleep disorders, acute traumatic stress and inflammatory responses.
Elderly people have underlying diseases such as decreased multi-system functions (for example, organ-specific or chronic diseases) and decreased sensory functions (for example, visual and hearing impairments), and hip fractures can cause pain and functional loss. Pain is A Class A risk factor for POD, and about 42 percent of elderly patients with hip fractures experience moderate to severe pain during the acute phase. Pain not only triggers the release of inflammatory factors but also reduces sleep quality, further increasing the risk of POD. Therefore, effective perioperative analgesia is crucial for reducing the incidence of POD.
Regional nerve block analgesia (such as iliofascial block, FIB) has been widely used in recent years because of its definite analgesic effect and few side effects. Bupivacaine liposomes, as a new type of long-acting local anesthetic, can achieve stable drug release within 72 hours after injection and provide long-acting analgesia, but its effect on POD is not yet clear. This study aims to explore the effect of bupivacaine liposomes on preemptive analgesia of iliofascial block on postoperative pain and POD in elderly patients with hip fractures.
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 (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hip fractures scheduled for surgical treatment (including femoral neck fractures, intertrochanteric fractures, and fractures more than 5 cm below the lesser trochanter of the femur).
- •Age ≥65 years.
- •American Society of Anesthesiologists (ASA) grade I - III.
- •The patient or family member signed the informed consent form
排除标准
- •Compound injuries (such as combined fractures of the head, chest, pelvis, or limbs).
- •Have a clear history of mental illness or are taking psychotropic drugs.
- •Preoperative delirium or the use of delirium-related medications (such as olanzapine).
- •A history of acute cerebrovascular disease (cerebral infarction or cerebral hemorrhage) within 6 months.
- •Patients requiring sedation or postoperative coma due to the condition.
- •Allergy to amide local anesthetics.
- •Severe arrhythmia or liver or kidney dysfunction
研究组 & 干预措施
intramuscularly
The elderly patients with hip fractures who were randomly divided into the control group were injected tramadol 100mg intramuscularly.
干预措施: Tramadol (Drug)
ultrasound-guided high iliofascial space block
The elderly patients with hip fractures who were randomly divided into the experimental group were given ultrasound-guided high iliofascial space block
干预措施: bupivacaine liposome (ultrasound-guided high iliofascial space block) (Drug)
结局指标
主要结局
POD incidence
时间窗: Evaluated twice daily within 3 days after surgery (8:00-10:00 and 18:00-20:00)
Evaluated via the CAM scale. * CAM diagnostic criteria: 1. Acute onset of mental changes and fluctuating course of the disease. 2. Inattentiveness. 3. Disordered thinking. 4. Changes in consciousness levels. * A POD is diagnosed if it meets 1+2 or 1+3 or 1+4.
次要结局
- Preoperative pain(before the surgery.)
- Number of participants with hemodynamic changes(during the operation)
- 30-day mortality(30-day after surgery)
- Postoperative pain(twice a day for 1-3 days after the operation)
- Anesthesia method form(during operation)
- Number of participants with Sleep quality(from hospitalization to 3 days after surgery(22:30-06:30).)
- Recovery quality(24 hours after surgery)
- intraoperative medication checklist(during operation)
- postoperative complications(Periprocedural)
- length of hospital stay(Periprocedural)
研究者
Hongwei Shi
Director, Department of Anesthesia, Pain and Perioperative Medicine
Nanjing First Hospital, Nanjing Medical University