A Analgesic Study of Adductor Canal &IPACK Block With Liposomal Bupivacaine in Knee Arthroplasty ：A Randomized，Double-controlled，Parallel-controlled，Single-center Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group
研究概览
简要总结
To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty
详细描述
The pain after knee arthroplasty limits the patient's activities and postoperative recovery, and currently there are mainly three analgesic methods: intravenous analgesia, epidural analgesia and nerve block analgesia. There is a lack of studies on whether liposomal bupivacaine, if used for ACB and iPACK block, can achieve benefits in knee arthroplasty pain management by prolonging sensory nerve block without affecting muscle strength, improving patient prognosis, and shortening hospitalization days.
In this study, in order to better evaluate the effect of liposomal bupivacaine for ACB and iPACK biock on the prognosis of patients undergoing knee arthroplasty, not only the NRS and AUC of patients in each group will be observed, but also the postoperative QoR-15 Quality of Recovery Rating Scale, postoperative nausea, vomiting and other complications, and the number of hospitalization days will be also included as observation indicators. The completion of this study can provide a clinical basis for the selection of analgesic regimens for knee arthroplasty, and also provide strong evidence-based medical support for the relevant medical decision making of government departments.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-79 years.
- •Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
- •Normal diet.
- •ASA grade I~Ⅲ;
- •BMI 18-30kg /m
- •No intraspinal anesthesia contraindications.
排除标准
- •Patients with severe neurological diseases.
- •Hearing and speech impaired.
- •Preoperative gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery, etc.
- •Patients with severe renal insufficiency or other severe metabolic diseases.
- •Mental disorders, alcoholism or a history of drug abuse.
- •The surgical time is greater than 3 hours.
- •Puncture site infection, abnormal coagulation function, and local anesthetic allergy.
结局指标
主要结局
The cumulative use of analgesic drugs (sufentanil,calculated in ug)up to 48 hours postoperative in each group
时间窗: Up to 48 hours postoperative
To study the effectiveness of ACB and iPACK block with liposomal bupivacaine for postoperative analgesia in patients undergoing knee arthroplasty.A lower dose of analgesics indicates a longer duration of block.
次要结局
- NRS scores at rest and during exerciseat at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative(at 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours postoperative)
- The total number of PCIA compressions on the first day,the second day and the third day after surgery.(On the first day,the second day and the third day after surgery.)
- The number of effective PCIA compressions on the first day,the second day and the third day after surgery.(On the first day,the second day and the third day after surgery.)
- The number of times of remedial analgesia on the first day,the second day and the third day after surgery.(On the first day,the second day and the third day after surgery.)
- The cumulative use of analgesic drugs (sufentanil,calculated in ug)on the first day,the second day and the third day after surgery.(On the first day,the second day and the third day after surgery.)
- The percentage of subjects who did not use remedial analgesics on the first day,the second day and the third day after surgery.(On the first day,the second day and the third day after surgery.)
- Satisfaction score of subjects on the first day,the second day and the third day after surgery.(On the first day,the second day and the third day after surgery.)
- Satisfaction score of surgeons on the first day,the second day and the third day after surgery.(On the first day,the second day and the third day after surgery.)
- Both the liposomal bupivacaine group and the ropivacaine group were subjected to ACB and iPACK block. Area under the pain intensity-time curve within 72 hours after the first postoperative dose(PI-AUC72)was observed in the three groups.(within 72 hours after the first postoperative initiation of drug administration)
- 15-item Quality of Recovery Rating Scale (QoR-15): 24hours, 48hours and 72hours postoperatively(at 24 hours, 48 hours and 72 hours postoperative)