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

Phase 4

• Conditions: Hepatic Arterial Infusion Chemotherapy; Pain; Transarterial Chemoembolization; Hepatocellular Carcinoma
• Interventions: Drug: Sufentanil; Drug: Esketamine

• Registration Number: NCT05416073
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-20
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-13
• Study Start: 2022-06-22
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
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.

Primary Outcome Measures

Name	Time	Method
Maximum pain intensity in the first 3 hours of HAIC treatment	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	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	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	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)

Secondary Outcome Measures

Name	Time	Method
Pain intensity at 8 hours after HAIC treatment	From 7 hours to 8 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 16 hours after HAIC treatment	From 15 hours to 16 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 32 hours after HAIC treatment	From 31 hours to 32 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 48 hours after HAIC treatment	From 47 hours to 48 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 on the seventh days after HAIC treatment	From 7 days to 8 days 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)
Analgesic consumption	From the beginning of HAIC treatment to 48 hours after HAIC treatment	Analgesic consumption is assessed by the total amount of pain remedy with dolantin when the analgesic effect is poor after pressing analgesic pump for 3 times or more
Pain intensity at 24 hours after HAIC treatment	From 23 hours to 24 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 40 hours after HAIC treatment	From 39 hours to 40 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 on the 21st after HAIC treatment	From 20 days to 21 days 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)
Numbers of analgesic pump compressions	From the beginning of HAIC treatment to 48 hours after HAIC treatment	When the patients felt pain, the patient controlled analgesia pump can be pressed once
Pain intensity On the 14th day after HAIC treatment	From 13 days to 14 days 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)

Trial Locations

Locations (1)

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