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

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

NCT ID: NCT05670561

Condition: Hepatocellular Carcinoma
Transcatheter Arterial Chemoembolization
Pain

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Abdominal Pain
Abdomen, Acute
Sufentanil
Esketamine

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Intervention:

Intervention type: Drug
Intervention name: Esketamine
Description: 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.The PCIA pump was commenced at the beginning of TACE. 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.
Arm group label: Esketamine-PCIA(patient controlled intravenous analgesia)

Other name: patient controlled intravenous analgesia

Intervention type: Drug
Intervention name: Sufentanil
Description: 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. The PCIA pump was commenced at the beginning of TACE. 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.
Arm group label: Sufentanil-PCIA(patient controlled intravenous analgesia)

Other name: patient controlled intravenous analgesia

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Second Affiliated Hospital, Chongqing Medical University

Address:
City: Chongqing
Zip: 400010
Country: China

Status: Recruiting

Contact:
Last name: Duan Guangyou, MD

Phone: 18323376014

Phone ext: +86
Email: duangy@hospital.cqmu.edu.cn

Start date: January 5, 2023

Completion date: July 30, 2023

Lead sponsor:
Agency: The Second Affiliated Hospital of Chongqing Medical University
Agency class: Other

Source: The Second Affiliated Hospital of Chongqing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05670561