Analgesic Effect of Ropivacaine Hydrochloride Combined With Hydromorphone Hydrochloride for Combined Spinal-epidural Anesthesia After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Incidence of moderate to severe pain at rest at 6, 12, 18, and 24 hours after anesthesia.
研究概览
简要总结
The aim of this study is to investigate the continuous analgesic effect and side effects of ropivacaine combined with hydromorphone for combined spinal-epidural anesthesia(CSEA) after total knee arthroplasty and to explore its clinical application value. To observe whether hydromorphone combined with ropivacaine can promote the rapid recovery of patients.
详细描述
For patients undergoing total knee arthroplasty, different spinal anesthesia drugs were injected in the two groups. The spinal anesthetic drugs injected in the hydromorphone group were hydromorphone 50 μg and ropivacaine 15 mg. In the control group, the spinal anesthetic was ropivacaine 15 mg.The differences in analgesia, sedation, and side effects between the hydromorphone group and the control group were analyzed by collecting various data at different times after anesthesia.
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 (Participant, Care Provider)
盲法说明
The participants, the surgeon, the surgical nurse, the data collector, and the anesthesiologist administering anesthesia were not aware of the patient groups
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 55 and 80 years old.
- •ASA grade I to III.
- •BMI:20-29kg/m
- •No recent use of sedatives, opioids, or other analgesics.
- •There was no contraindication of spinal anesthesia, severe dysfunction of heart, lung and other important organs or serious systemic diseases.
- •Patients were willing to participate in the study and signed the informed consent.
排除标准
- •The patient has mental illness or cannot cooperate with the completion of spinal anesthesia.
- •The patient had a history of spinal surgery and spinal deformity.
- •Patients had a history of opioid intolerance or adverse reactions.
- •puncture site infection, coagulopathy or recent use of anticoagulant drugs.
- •History of allergy to local anesthetics.
- •Failed puncture.
- •Unable to cooperate to complete the research process.
研究组 & 干预措施
Hydromorphone group
Hydromorphone 50 micrograms combined with ropivacaine 15 mg was injected into the subarachnoid space
干预措施: Hydromorphone was injected into the subarachnoid space (Drug)
结局指标
主要结局
Incidence of moderate to severe pain at rest at 6, 12, 18, and 24 hours after anesthesia.
时间窗: 6, 12, 18, and 24 hours after anesthesia
The NRS scale was used to evaluate pain scores at rest at 6, 12, 18, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)
Incidence of moderate to severe pain with movement at 6, 12, 18, and 24 hours after anesthesia.
时间窗: 6, 12, 18, and 24 hours after anesthesia
NRS rating scale was used to evaluate pain score during movement at 6 hours, 12 hours, 18 hours, and 24 hours after anesthesia；Numeric rating scale (NRS, an 11-point scale where 0=no pain and 10=worst possible pain)
次要结局
- Sedation and agitation at 6, 12, 18 and 24 hours after anesthesia(6, 12, 18, and 24 hours after anesthesia)
- Total non-steroidal analgesic drug consumption 48 hours after surgery(Postoperative 48 hours)
- Length of postoperative hospital stay(2 weeks after surgery)
- The incidence of postoperative nausea or vomiting(Postoperative 48 hours)
- The incidence of intraoperative hypoxemia(During the operation)
- Incidence of intraoperative HR reduction(During the operation)
- Satisfaction with postoperative analgesia(5 days after surgery)
- Retention time of urinary tube(5 days after surgery)
- The number of effective compressions of PCIA at 24 hours after surgery(Postoperative 24 hours)
- The proportion of the required additional analgesia after 24 hours(Postoperative 24 hours)
- Total opioid analgesic consumption at 48 hours after surgery(Postoperative 48 hours)
- The proportion of getting out of bed within 48h(Postoperative 48 hours)
- The incidence of postoperative pruritus(Postoperative 48 hours)
- The incidence of intraoperative hypotension(During the operation)