Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma: a Prospective Study TACE-HAIC (Transcatheter Arterial Chemoembolization Combined With Hepatic Artery Infusion Chemotherapy )
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Maximum pain intensity in the first 3 hours of HAIC treatment
研究概览
简要总结
Previous studies have confirmed that limb pain caused by oxaliplatin chemotherapy is related to spinal cord central sensitization - induced hyperalgesia through oxaliplatin activating spinal cord NMDA receptor(N-methyl-D-aspartic acid receptor). The investigators speculate that this may be the same as the mechanism of severe abdominal pain caused by HAIC(Hepatic Artery Infusion Chemotherapy) during oxaliplatin infusion. The analgesic effect of Esketamine is mainly related to its inhibition of NMDA receptor in spinal cord. Therefore, this study hypothesized that Esketamine can inhibit the sensitization of spinal cord center by inhibiting NMDA receptor, so as to alleviate severe abdominal pain during HAIC perfusion, and reduce abdominal pain caused by ischemia and inflammation by TACE(transcatheter arterial chemoembolization) by improving organ perfusion and anti-inflammatory effect, Therefore, it is expected that Esketamine can better alleviate acute severe abdominal pain caused by TACE-HAIC (transcatheter arterial chemoembolization combined with Hepatic Artery Infusion Chemotherapy )treatment than sufentanil, decrease the dosage of opioids, and reduce the incidence and degree of chronic abdominal pain after treatment.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participate in this study and sign informed consent
- •Voluntarily receive postoperative intravenous controlled analgesia
- •Patients receiving TACE-HAIC treatment
- •HCC (hepatocellular carcinoma)patients with primary liver cancer BCLC(Barcelona Clinic Liver Cancer) stage B and C, liver function A
- •Age 18 to 80
排除标准
- •Patients who were unable to cooperate or refused to participate in the trial
- •Pregnant women
- •Patients with sensory abnormalities such as diabetes neuropathy
- •Patients with or having a history of serious mental disorders
- •Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic / diastolic blood pressure more than 180/100mg)
- •Patients with unstable angina pectoris or myocardial infarction within 6 months or congestive heart failure
- •Patients with intracranial hypertension or glaucoma
- •Patients with hyperthyroidism without treatment or insufficient treatment
- •Patients with severe respiratory dysfunction
- •Allergy or existing contraindication to chemotherapeutic drugs, opioids or ketamine drugs
- •Can not follow with the study procedure
研究组 & 干预措施
Esketamine-PCIA(patient controlled intravenous analgesia)
PCIA formula：100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline.
干预措施: Esketamine (Drug)
Sufentanil-PCIA(patient controlled intravenous analgesia)
PCIA formula：100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Maximum pain intensity in the first 3 hours of HAIC treatment
时间窗: From the beginning of HAIC treatment to 3 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Pain intensity at 2 hours after HAIC treatment
时间窗: From 1 hour to 2 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Pain intensity at 1 hour after HAIC treatment
时间窗: From the beginning of HAIC treatment to 1 hour after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
Pain intensity at 3 hours after HAIC treatment
时间窗: From 2 hours to 3 hours after HAIC treatment
Pain intensity is assessed by numerical rating scale pain scores (0-10, 0 represents painless; 10 represents intolerable pain;higher scores mean a worse outcome)
次要结局
- Pain intensity at 8 hours after HAIC treatment(From 7 hours to 8 hours after HAIC treatment)
- Pain intensity at 16 hours after HAIC treatment(From 15 hours to 16 hours after HAIC treatment)
- Pain intensity at 32 hours after HAIC treatment(From 31 hours to 32 hours after HAIC treatment)
- Pain intensity at 48 hours after HAIC treatment(From 47 hours to 48 hours after HAIC treatment)
- Pain intensity on the seventh days after HAIC treatment(From 7 days to 8 days after HAIC treatment)
- Analgesic consumption(From the beginning of HAIC treatment to 48 hours after HAIC treatment)
- Pain intensity at 24 hours after HAIC treatment(From 23 hours to 24 hours after HAIC treatment)
- Pain intensity at 40 hours after HAIC treatment(From 39 hours to 40 hours after HAIC treatment)
- Pain intensity on the 21st after HAIC treatment(From 20 days to 21 days after HAIC treatment)
- Numbers of analgesic pump compressions(From the beginning of HAIC treatment to 48 hours after HAIC treatment)
- Pain intensity On the 14th day after HAIC treatment(From 13 days to 14 days after HAIC treatment)