A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale（VAS）
研究概览
简要总结
Total hip arthroplasty is currently the most effective method for treating hip joint lesions and improving quality of life, but postoperative severe pain is not conducive to rapid recovery of patients. In recent years, the widespread application of ultrasound has achieved good clinical results in iliac fascia block for postoperative analgesia in THA. However, the use of high-dose local anesthetics can increase the risk of local anesthetic poisoning, and the single block analgesia time is generally less than 24 hours. Methylene blue, as a long-acting analgesic drug, can block the pain transmission of nerve fibers for a long time, achieving analgesic effects without damaging neurons. This study used ultrasound-guided ropivacaine combined with methylene blue to perform iliac fascia block on patients undergoing total hip replacement, with the aim of prolonging pain relief time, reducing complications, and promoting postoperative recovery on the basis of traditional methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip replacement surgery is indicated
- •ASA Class II - Class III
- •No history of analgesic or local anesthetic allergy
- •No history of alcohol abuse or narcotic drug abuse
- •Patients and their families have given informed consent and signed the informed consent form
排除标准
- •Patient or family refusal to participate in the study
- •Severe coagulation abnormalities
- •Local anesthetic allergy
- •Severe psychiatric illness or other communication disorder
- •There is an infection at the puncture site
- •History of neurological disease such as Guillain-Barré syndrome
- •Delay in awakening post-surgery for more than 60 min,
- •Post-surgical use of an analgesic pump
- •Inability to follow-up at the required time points.
研究组 & 干预措施
0.25% ropivacaine+0.05% methylene blue 30ml for iliac fascia block
干预措施: Ropivacaine combined with methylene blue for iliac fascia block (Drug)
结局指标
主要结局
Visual Analogue Scale（VAS）
时间窗: From enrollment to 48 hours after surgery， the VAS scores at both rest and with activity (passive straight leg raise at 45°) were recorded at the following time points: before block and at 2, 6, 12, 24, and 48 h postoperatively
Use a swimming ruler about 10 cm long, marked with 10 ticks on one side, and "0" and "10" at each end. A score of 0 indicates no pain, a score of 10 indicates the most severe pain that is unbearable, and the higher the score, the greater the degree of pain
次要结局
- Hypersensitive C-reactive Protein(From enrollment to 48 hours after surgery)
- Procalcitonin(From enrollment to 48 hours after surgery)
- Neutrophil Lymphocyte Ratio(From enrollment to 48 hours after surgery)
- Mean Arterial Pressure(From entering the operating room to leaving the resuscitation room)
- Heart Rate(From entering the operating room to leaving the resuscitation room)
- Duration of Surgery(Intraoperative)
- Number of Postoperative Salvage Analgesia(From the end of surgery to 48 hours after surgery)
- Walking Distance for the First Time Getting Out of Bed(From the end of surgery to 48 hours after surgery)
- The Number of Activities of Getting Out of Bed 48 Hours After Surgery(From the end of surgery to 48 hours after surgery)
研究者
Wang wanxia
Principal Investigator
Yangzhou University