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

NCT ID: NCT05416073

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2023-04-30

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.

Conditions

Hepatocellular Carcinoma; Transarterial Chemoembolization; Hepatic Arterial Infusion Chemotherapy; 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. After that, the intravenous analgesia pump was started. 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. After that, the intravenous analgesia pump was started. 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. After that, the intravenous analgesia pump was started. 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. After that, the intravenous analgesia pump was started. 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

• 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

• 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

Huang yan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Guangyou Duan, MD

Role: primary

duangy@hospital.cqmu.edu.cn

(+86)18323376014

Other Identifiers

pain during TACE-HAIC

Identifier Type: -

Identifier Source: org_study_id