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

NCT05416073 | Unknown Phase 4 DMC

• 1 other identifier: pain during TACE-HAIC
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Maximum pain intensity in the first 3 hours of 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)

  From the beginning of HAIC treatment to 3 hours after HAIC treatment

• Pain intensity at 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)

  From the beginning of HAIC treatment to 1 hour after HAIC treatment

• Pain intensity at 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)

  From 1 hour to 2 hours after HAIC treatment

• Pain intensity at 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)

  From 2 hours to 3 hours after HAIC treatment

Secondary Outcomes (11)

• Numbers of analgesic pump compressions

  From the beginning of HAIC treatment to 48 hours after HAIC treatment

• Analgesic consumption

  From the beginning of HAIC treatment to 48 hours after HAIC treatment

• Pain intensity at 8 hours after HAIC treatment

  From 7 hours to 8 hours after HAIC treatment

• Pain intensity at 16 hours after HAIC treatment

  From 15 hours to 16 hours after HAIC treatment

• Pain intensity at 24 hours after HAIC treatment

  From 23 hours to 24 hours after HAIC treatment

Other Outcomes (9)

• Ramsay Sedation score at 1 hour after HAIC treatment

  From the beginning of HAIC treatment to 1 hour after HAIC treatment

• Ramsay Sedation score at 2 hours after HAIC treatment

  From 1 hour to 2 hours after HAIC treatment

• Ramsay Sedation score at 3 hours after HAIC treatment

  From 2 hours to 3 hours after HAIC treatment

Study Arms (2)

Esketamine-PCIA(patient controlled intravenous analgesia)

EXPERIMENTAL

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

Drug: Esketamine

Sufentanil-PCIA(patient controlled intravenous analgesia)

ACTIVE COMPARATOR

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

Drug: Sufentanil

Interventions

Esketamine 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.

Also known as: patient controlled intravenous analgesia

Esketamine-PCIA(patient controlled intravenous analgesia)

Sufentanil 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.

Also known as: patient controlled intravenous analgesia

Sufentanil-PCIA(patient controlled intravenous analgesia)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Pain

Interventions

Esketamine; Sufentanil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Huang He, MD

  The Second Affiliated Hospital, Chongqing Medical University

  STUDY CHAIR

• Huang yan, MD

  The Second Affiliated Hospital, Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duan Guang you, MD

CONTACT

18323376014; duangy@hospital.cqmu.edu.cn

wang Da gang, MD

CONTACT

023 63693014; kuanrenlunli@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 13, 2022
• Study Start: June 22, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: February 24, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within one year

Locations

CN (1)