Effect of Esketamine Combined With Butorphanol on Pain Management Following Video-assisted Lobectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Incidence of chronic pain
研究概览
简要总结
Post-thoracotomy pain syndrome (PTPS) affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. The analgesic effect of esketamine combined with butorphanol in PTPS is still unclear, so this study focused on this aspect.
详细描述
Post-thoracotomy pain syndrome affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. Esketamine, the left-handed optical isomer of racemic ketamine, acts as an antagonist of the N-methyl-D-aspartate (NMDA) receptor, reversing central sensitization and improving postoperative pain. Butorphanol, an opioid receptor agonist-antagonist, can alleviate visceral pain, reduce the risk of respiratory depression, and decrease postoperative morphine consumption. However, research on the analgesic effects of esketamine combined with butorphanol in thoracoscopic surgery remains limited. Therefore, this study investigated the impact of esketamine combined with butorphanol on acute pain, chronic pain, and related side effects during the perioperative period in patients undergoing video-assisted lobectomy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-70 years
- •Classified as American Society of Anesthesiologists I-III
- •Undergoing video-assisted lobectomy
排除标准
- •Operative duration < 1 hour
- •Significant comorbidities affecting vital organs such as liver, kidney, and heart
- •Severe infections
- •Immunodeficiency
- •Coagulation disorders
- •History of analgesic drug abuse
- •Severe dementia or communication barriers
- •Mental illnesses.
研究组 & 干预措施
Group BK
Group BK received esketamine infusion at a rate of 0.3 mg/kg/h during surgery. Patients were provided with patient-controlled intravenous analgesia (PCIA) containing esketamine (1.5 mg/kg), butorphanol (0.15 mg/kg), and azasetron (20 mg) in a total volume of 100 ml within 48 hours after surgery.
干预措施: Esketamine (Drug)
Group BK
Group BK received esketamine infusion at a rate of 0.3 mg/kg/h during surgery. Patients were provided with patient-controlled intravenous analgesia (PCIA) containing esketamine (1.5 mg/kg), butorphanol (0.15 mg/kg), and azasetron (20 mg) in a total volume of 100 ml within 48 hours after surgery.
干预措施: Butorphanol (Drug)
Group B
Group B received an equivalent volume of saline during surgery. Patients were provided with patient-controlled intravenous analgesia (PCIA) containing butorphanol (0.15 mg/kg), and azasetron (20 mg) in a total volume of 100 ml within 48 hours after surgery.
干预措施: Butorphanol (Drug)
结局指标
主要结局
Incidence of chronic pain
时间窗: 3 months post-surgery
To assess the patient's subjective pain intensity through the Visual Analog Pain Scale at 3 months after surgery. The Visual Analog Pain Scale consists of a line usually 100 mm in length. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (no pain) to the right (worst pain). The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.
次要结局
- Heart rate(During operation)
- Acute pain after surgery(Within 7 days after surgery)
- Postoperative recovery quality(Preoperative and within 3 days after surgery)
- Intraoperative mean arterial pressure(During operation)
研究者
Wang Hongjian
Attending doctor
Second People's Hospital of Hefei City