NCT05416073

Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma

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 )

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatocellular Carcinoma
• Transarterial Chemoembolization
• Hepatic Arterial Infusion Chemotherapy
• Pain

Interventions

Type	Name	Description
DRUG	Esketamine	PCIA formula：100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline. 30min before TACE treatment, the first dose of 2ml was slowly injected intravenously. No obvious adverse reactions were observed for 10min. After that, the intravenous analgesia pump was started. Parameter setting of intravenous analgesia pump: the total volume is 100ml; The duration is 2ml / h; The single dose is 2ml each time; The limit quantity is 10ml / h; The locking time was 10min and the analgesia lasted for 48h. The target value of analgesia in this study was NRS (Numerical Rating Scale)\< 4; If NRS ≥ 4, when the effect is still poor after adding drugs by pressing the analgesic pump, the investigators will give the remedial drug(dolantin 50mg im st) according to the patient's condition.
DRUG	Sufentanil	PCIA formula：100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline. 30min before TACE treatment, the first dose of 2ml was slowly injected intravenously. No obvious adverse reactions were observed for 10min. After that, the intravenous analgesia pump was started. Parameter setting of intravenous analgesia pump: the total volume is 100ml; The duration is 2ml / h; The single dose is 2ml each time; The limit quantity is 10ml / h; The locking time was 10min and the analgesia lasted for 48h. The target value of analgesia in this study was NRS (Numerical Rating Scale)\< 4; If NRS ≥ 4, when the effect is still poor after adding drugs by pressing the analgesic pump, the investigators will give the remedial drug(dolantin 50mg im st) according to the patient's condition.

Timeline

• Start date: 2022-06-22
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2022-06-13
• Last updated: 2023-02-24

Locations

1 site across 1 country: China