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

NCT ID: NCT05670561

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2023-07-30

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.

Conditions

Hepatocellular Carcinoma; Transcatheter Arterial Chemoembolization; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Esketamine-PCIA(patient controlled intravenous analgesia)

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

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

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.

Sufentanil-PCIA(patient controlled intravenous analgesia)

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

Group Type: ACTIVE_COMPARATOR

Sufentanil

Intervention Type: DRUG

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.

Interventions

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.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.

Intervention Type: 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. 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.

Intervention Type: DRUG

Other Intervention Names

patient controlled intravenous analgesia; patient controlled intravenous analgesia

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huang He, MD

Role: STUDY_CHAIR

The Second Affiliated Hospital, Chongqing Medical University

Locations

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Duan Guang you, MD

Role: CONTACT

duangy@hospital.cqmu.edu.cn

18323376014 ext. +86

Wang Da gang, MD

Role: CONTACT

kuanrenlunli@qq.com

023 63693014 ext. +86

Facility Contacts

Duan Guangyou, MD

Role: primary

duangy@hospital.cqmu.edu.cn

18323376014 ext. +86

Other Identifiers

pain after TACE

Identifier Type: -

Identifier Source: org_study_id