Study on the Analgesic Effect of Tegileridine Combined With Intercostal Nerve Block After Thoracoscopic Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- VAS (Visual Analog Scale) pain score
研究概览
简要总结
Combining tegileridine PCIA with ICNB targeting peripheral nerves, may constitute an ideal analgesic model with complementary advantages. Thus potentially achieving the analgesic goal of "early pain relief, stable throughout the process, and rapid recovery," and may have a positive impact on reducing CPSP.
详细描述
Combining tegileridine PCIA with ICNB targeting peripheral nerves, may constitute an ideal analgesic model with complementary advantages. ICNB provides rapid and precise incision analgesia in the early postoperative period, effectively blocking the transmission of peripheral nociceptive stimuli to the central nervous system. tegileridine PCIA, on the other hand, enhances the function of the endogenous descending pain suppression system through its central G protein pathway activation, covering the pain period after the effect of ICNB wears off and components such as visceral referred pain. At the same time, it can effectively reduce side effects such as respiratory depression and nausea/vomiting, thus potentially achieving the analgesic goal of "early pain relief, stable throughout the process, and rapid recovery," and may have a positive impact on reducing CPSP.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18 to 75 years old;
- •Patients undergoing elective thoracoscopic lobectomy or segmentectomy;
- •ASA classification levels I-III;
- •BMI 18 ~ 30 kg/m2。
- •Voluntarily participate and sign an informed consent form.
排除标准
- •Patients with preoperative alcohol dependence and long-term use of analgesic drugs are receiving analgesic treatment for other acute and chronic pain;
- •Pregnant or lactating women;
- •Allergies or other contraindications to the anesthetics, analgesics, and antiemetic drugs used in the study;
- •Patients with severe sleep apnea syndrome or acute or severe bronchial asthma;
- •Suffering from mental and neurological disorders or cognitive impairment, known or suspected gastrointestinal obstruction, severe liver and kidney dysfunction (Child Pugh score C), chronic obstructive pulmonary disease or severe cardiovascular disease, etc;
- •Researchers consider participants who are not suitable to participate in this study and those who refuse to participate.
研究组 & 干预措施
sufentanil group
Administer 0.15 μg/kg (maximum 10 μg) of sufentanil intravenously 40 minutes before the end of surgery, followed by the connection of a sufentanil patient-controlled intravenous analgesia (PCIA). Analgesic pump formula: Sufentanil 150 μg + 0.9% normal saline, total volume 150 mL (containing sufentanil 1 μg/mL). PCIA settings: Single loading dose 1 mL (containing sufentanil 1 μg), lockout interval 10 min, background infusion 1 mL/h.
干预措施: Sufentanil (Drug)
sufentanil group
Administer 0.15 μg/kg (maximum 10 μg) of sufentanil intravenously 40 minutes before the end of surgery, followed by the connection of a sufentanil patient-controlled intravenous analgesia (PCIA). Analgesic pump formula: Sufentanil 150 μg + 0.9% normal saline, total volume 150 mL (containing sufentanil 1 μg/mL). PCIA settings: Single loading dose 1 mL (containing sufentanil 1 μg), lockout interval 10 min, background infusion 1 mL/h.
干预措施: Intercostal Nerve Block (Procedure)
Tegileridine group
Administer 0.015 mg/kg (maximum 1mg) of tegileridine intravenously 40 minutes before the end of surgery, followed by the connection of a tegileridine patient-controlled intravenous analgesia (PCIA). Analgesic pump formula: Tigrilidine 15,000 μg + 0.9% normal saline, total volume 150 mL (containing Tigrilidine 100 μg/mL). PCIA settings: Single loading dose 1 mL (containing Tigrilidine 100 μg), lockout interval 10 min, background infusion 1 mL/h.
干预措施: Intercostal Nerve Block (Procedure)
Tegileridine group
Administer 0.015 mg/kg (maximum 1mg) of tegileridine intravenously 40 minutes before the end of surgery, followed by the connection of a tegileridine patient-controlled intravenous analgesia (PCIA). Analgesic pump formula: Tigrilidine 15,000 μg + 0.9% normal saline, total volume 150 mL (containing Tigrilidine 100 μg/mL). PCIA settings: Single loading dose 1 mL (containing Tigrilidine 100 μg), lockout interval 10 min, background infusion 1 mL/h.
干预措施: Tegileridine (Drug)
结局指标
主要结局
VAS (Visual Analog Scale) pain score
时间窗: 48 hours
VAS pain score 0-10, the higher scores mean a worse outcome; Analgesic effect assessed during activity in the post-anesthesia care unit (PACU) and at 1, 6, 12, 24, 36, and 48 hours post-surgery
次要结局
- total dosage of remedial analgesic drugs(48hours)
- the number of rescue analgesic interventions(48 hours)
- overall patient satisfaction(10 days)
- doses of remedial analgesic drugs(48hours)
- PCIA-related parameters(48 hours)
- Incidence of opioid-related adverse events (ORAEs)(48 hours)
- The length of postoperative hospital stay(10 days)
- The quality of sleep(10 days)