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

Phase 4

Recruiting

• Conditions: Hepatocellular Carcinoma; Transcatheter Arterial Chemoembolization; Pain
• Interventions: Drug: Esketamine; Drug: Sufentanil

• Registration Number: NCT05670561
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-02
• Study First Posted: 2023-01-04
• Study Start: 2023-01-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esketamine-PCIA(patient controlled intravenous analgesia)	Esketamine	PCIA formula#100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline.
Sufentanil-PCIA(patient controlled intravenous analgesia)	Sufentanil	PCIA formula#100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline.

Primary Outcome Measures

Name	Time	Method
Pain Intensity at 4hours after the beginning of TACE operation	From 0 to 4hours after the beginning of TACE	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 12hours after the beginning of TACE operation	From 8hours to 12hours after the beginning of TACE operation	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 8hours after the beginning of TACE operation	From 4hours to 8hours after the beginning of TACE operation	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)

Secondary Outcome Measures

Name	Time	Method
Pain Intensity at 30hours after the beginning of TACE operation	From 24hours to 30hours after the beginning of TACE operation	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 36hours after the beginning of TACE operation	From 30hours to 36hours after the beginning of TACE operation	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)
Maximum Pain Intensity in the First 4hours after the beginning of TACE operation	From the beginning of TACE operation to 4hours after the beginning of TACE operation	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)
Maximum Pain Intensity in the Third 4hours after the beginning of TACE operation	From 8hours to 12hours after the beginning of TACE operation	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 18hours after the beginning of TACE operation	From 12hours to 18hours after the beginning of TACE operation	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)
Maximum Pain Intensity in the Second 4hours after the beginning of TACE operation	From 4hours to 8hours after the beginning of TACE operation	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 42hours after the beginning of TACE operation	From 36hours to 42hours after the beginning of TACE operation	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 24hours after the beginning of TACE operation	From 18hours to 24hours after the beginning of TACE operation	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 48hours after the beginning of TACE operation	From 42hours to 48hours after the beginning of TACE operation	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)
Analgesic Consumption	From 0 to 48 hours after the beginning of TACE operation	Analgesic consumption is assessed by the total amount of pain remedy with dolantin when the analgesic effect is poor.

Trial Locations

Locations (1)

The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China