Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery: a Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 148
- 试验地点
- 1
研究概览
简要总结
Patients after hip surgery often suffer from severe pain. Inadequate analgesia increases the risk of postoperative delirium, myocardial injury, and other complications. Peripheral nerve block is an important component of multimodal analgesia, but conventional local anesthetics (such as plain bupivacaine) provide only approximately 12 hours of analgesic duration, which is far from covering the most painful 72 hours after surgery. Liposomal bupivacaine has a slow-release property, prolonging the analgesic duration up to 72 hours after a single injection. However, its clinical advantages in hip fracture surgery remain controversial. The investigators suppose that, compared with plain bupivacaine alone, preoperative supra-inguinal fascia iliaca block using liposomal bupivacaine combined with plain bupivacaine can further improve analgesia, decrease opioid consumption, and improve postoperative recovery quality within 72 hours in older patients after hip fracture surgery.
详细描述
Hip joint diseases are among the major disorders that impair patients' motor function and quality of life. With the acceleration of population aging and the advancement of hip reconstruction techniques, the number of patients undergoing hip arthroplasty has continued to increase. Hip arthroplasty primarily includes hemiarthroplasty and total hip arthroplasty (THA), with indications covering a variety of diseases and injuries, including osteonecrosis of the femoral head, hip osteoarthritis, ankylosing spondylitis, developmental dysplasia of the hip, and other conditions that lead to structural destruction and functional impairment of the hip joint. Hip arthroplasty can effectively relieve pain, improve joint function, and enhance patients' quality of life, and has become an important treatment modality for end-stage hip joint diseases.
Optimizing analgesia through multimodal strategies can enhance postoperative recovery and shorten hospital stays. Peripheral nerve blocks (PNB), particularly ultrasound-guided femoral nerve block or supra-inguinal fascia iliaca compartment block (FICB), have been shown to reduce pain and opioid consumption after hip surgery. A recent prospective cohort study indicated that better perioperative pain control with PNB is associated with lower opioid needs and shorter hospitalization.
Conventional local anesthetics like ropivacaine or bupivacaine provide analgesia for about 12 hours, which is insufficient for the entire perioperative period. Liposomal bupivacaine, an extended-release formulation, can provide analgesia for up to 72 hours. Some studies have demonstrated benefits of liposomal bupivacaine for nerve blocks in thoracic and hip surgeries, including improved recovery quality, reduced opioid use, and lower pain scores at 24-72 hours. However, evidence remains controversial; several meta-analyses suggest that while statistical differences exist, clinical relevance may be limited.
Inadequate pain control negatively affects postoperative outcomes and is associated with delirium, myocardial injury, and pulmonary complications-especially in vulnerable older patients with reduced physiological reserve and multiple comorbidities. Therefore, this randomized controlled trial aims to investigate whether preoperative FICB using liposomal bupivacaine combined with plain bupivacaine can provide superior perioperative analgesia compared with plain bupivacaine alone in older (≥55 years) patients undergoing hip fracture surgery.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years.
- •Scheduled to undergo hip replacement surgery.
- •Agree to receive regional nerve block and postoperative patient-controlled intravenous analgesia (PCIA).
排除标准
- •Inability to communicate due to visual, auditory, language, or other reasons before surgery.
- •Chronic opioid dependence and long-term use of various types of analgesics (for more than 3 months).
- •Severe coagulation abnormalities (International Normalized Ratio > 1.7, activated partial thromboplastin time exceeding the normal value by more than 4 seconds, platelet count < 80 × 10⁹/L), trauma or infection at the intended puncture site, or severe low back pain.
- •Preoperative severe renal insufficiency (serum creatinine > 442 μmol/L or requiring renal replacement therapy), hepatic insufficiency (Child-Pugh class C), or ASA physical status > IV.
- •Known allergy to local anesthetics.
- •Any other condition that the investigator or attending physician deems unsuitable for participation in the study.
研究组 & 干预措施
Liposomal bupivacaine group
Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), for a total volume of 30 mL. The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.
干预措施: Liposomal bupivacaine (LB) (Drug)
Plain bupivacaine group
Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 30 mL of 0.5% plain bupivacaine (total 150 mg). The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.
干预措施: Plain bupivacaine (Drug)
研究者
Dong-Xin Wang
Chief Physician, Professor
Peking University First Hospital