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

NCT05670561 | Unknown Phase 4 DMC

• 1 other identifier: pain after TACE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Pain Intensity at 4hours after the beginning of TACE operation

  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 0 to 4hours after the beginning of TACE

• Pain Intensity at 8hours after the beginning of TACE operation

  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 4hours to 8hours after the beginning of TACE operation

• Pain Intensity at 12hours after the beginning of TACE operation

  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 8hours to 12hours after the beginning of TACE operation

Secondary Outcomes (10)

• Pain Intensity at 18hours after the beginning of TACE operation

  From 12hours to 18hours after the beginning of TACE operation

• Pain Intensity at 24hours after the beginning of TACE operation

  From 18hours to 24hours after the beginning of TACE operation

• Pain Intensity at 30hours after the beginning of TACE operation

  From 24hours to 30hours after the beginning of TACE operation

• Pain Intensity at 36hours after the beginning of TACE operation

  From 30hours to 36hours after the beginning of TACE operation

• Pain Intensity at 42hours after the beginning of TACE operation

  From 36hours to 42hours after the beginning of TACE operation

Other Outcomes (10)

• Ramsay Sedation Score at 1 hour after the beginning of TACE operation

  From 0 to 1hour after the beginning of TACE operation

• Ramsay Sedation Score at 2 hours after the beginning of TACE operation

  From 1hour to 2hours after the beginning of TACE operation

• Ramsay Sedation Score at 3 hours after the beginning of TACE operation

  From 2hours to 3hours after the beginning of TACE operation

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.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.

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. 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.

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:

• 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

You may not qualify if:

• 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

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

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: January 2, 2023
• First Posted: January 4, 2023
• Study Start: January 5, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-02

Data Sharing

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

Locations

CN (1)