Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma

Chongqing Medical University

Status and phase: Enrolling; Phase 4

Conditions: Hepatocellular Carcinoma; Pain; Transcatheter Arterial Chemoembolization

Treatments: Drug: Esketamine; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT05670561

pain after TACE

Details and patient eligibility

About

Pain is the main complication after TACE(Transcatheter Arterial Chemoembolization) for hepatocellular carcinoma, and its pathogenesis is not clear.The pain may be related to partial liver tissue swelling after blocking the tumor blood supply artery embolization agent, transient hepatic swelling causing tension or strain on the liver capsule, and chemical irritation by the anticancer drug-Lipiodol mixture,the inadvertent embolization of normal organs and individual sensitivity to pain. Ketamine produces anesthetic and analgesic effects mainly by inhibiting NMDA receptor(N-methyl-D-aspartic acid receptor), and previous studies have shown that low concentrations of ketamine have obvious analgesic effects. Not only that, ketamine also produces analgesic effects by inhibiting opioid receptors via G-protein coupling. In addition, ketamine can bind to monoaminergic receptors in the central and peripheral nervous system, showing an anticholinergic effect and producing an antispasmodic effect. Ketamine also inhibits inflammatory pain by reducing nitric oxide production by inhibiting nitric oxide synthase. Esketamine is about three to four times more potent than ketamine. Therefore,esketamine requires a lower dose, about half the dose of ketamine, to produce anesthetic and analgesic effects, with fewer side effects.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 80
• Participate in this study and sign informed consent
• Voluntarily receive preoperative intravenous analgesia
• Patients receiving TACE treatment
• HCC (hepatocellular carcinoma)patients with primary liver cancer BCLC(Barcelona Clinic Liver Cancer) stage A-C, liver function A-B

Exclusion criteria

• Patients who were unable to cooperate or refused to participate in the trial
• Pregnant women
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Esketamine-PCIA(patient controlled intravenous analgesia)

Experimental group

Description:

PCIA formula#100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline.

Treatment:

Drug: Esketamine

Sufentanil-PCIA(patient controlled intravenous analgesia)

Active Comparator group

Description:

PCIA formula#100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline.

Treatment:

Drug: Sufentanil