Clinical trial NCT05670561: Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma
Official title: Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma:a Prospective Study TACE(Transcatheter Arterial Chemoembolization)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Transcatheter Arterial Chemoembolization
Pain
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain Intensity at 4hours after the beginning of TACE operation
timeFrame: From 0 to 4hours after the beginning of TACE
measure: Pain Intensity at 8hours after the beginning of TACE operation
timeFrame: From 4hours to 8hours after the beginning of TACE operation
measure: Pain Intensity at 12hours after the beginning of TACE operation
timeFrame: From 8hours to 12hours after the beginning of TACE operation
Secondary outcomes:
measure: Pain Intensity at 18hours after the beginning of TACE operation
timeFrame: From 12hours to 18hours after the beginning of TACE operation
measure: Pain Intensity at 24hours after the beginning of TACE operation
timeFrame: From 18hours to 24hours after the beginning of TACE operation
measure: Pain Intensity at 30hours after the beginning of TACE operation
timeFrame: From 24hours to 30hours after the beginning of TACE operation
measure: Pain Intensity at 36hours after the beginning of TACE operation
timeFrame: From 30hours to 36hours after the beginning of TACE operation
measure: Pain Intensity at 42hours after the beginning of TACE operation
timeFrame: From 36hours to 42hours after the beginning of TACE operation
measure: Pain Intensity at 48hours after the beginning of TACE operation
timeFrame: From 42hours to 48hours after the beginning of TACE operation
measure: Maximum Pain Intensity in the First 4hours after the beginning of TACE operation
timeFrame: From the beginning of TACE operation to 4hours after the beginning of TACE operation
measure: Maximum Pain Intensity in the Second 4hours after the beginning of TACE operation
timeFrame: From 4hours to 8hours after the beginning of TACE operation
measure: Maximum Pain Intensity in the Third 4hours after the beginning of TACE operation
timeFrame: From 8hours to 12hours after the beginning of TACE operation
measure: Analgesic Consumption
timeFrame: From 0 to 48 hours after the beginning of TACE operation
Other outcomes:
measure: Ramsay Sedation Score at 1 hour after the beginning of TACE operation
timeFrame: From 0 to 1hour after the beginning of TACE operation
measure: Ramsay Sedation Score at 2 hours after the beginning of TACE operation
timeFrame: From 1hour to 2hours after the beginning of TACE operation
measure: Ramsay Sedation Score at 3 hours after the beginning of TACE operation
timeFrame: From 2hours to 3hours after the beginning of TACE operation
measure: The Quality of Sleep on the Day Just before TACE Treatment
timeFrame: From the day just before TACE treatment to the operation day
measure: The Quality of Sleep on the Operation Day
timeFrame: From the operation day to first day after TACE treatment
measure: The Quality of Sleep on the First Day after TACE Treatment
timeFrame: From the first day after TACE treatment to the second day after TACE treatment
measure: Adverse Reaction
timeFrame: From 0 to 48 hours after the beginning of TACE operation
measure: Degree of Satisfaction
timeFrame: From 0 to 24 hours after the beginning of TACE operation
measure: Quality-of-Life Assessment at the the beginning of TACE operation
timeFrame: From the beginning of TACE operation to 0 hour after the beginning of TACE operation
measure: Quality-of-Life Assessment at 24hours after the beginning of TACE operation
timeFrame: From 0 to 24 hours after the beginning of TACE operation
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital, Chongqing Medical University
name: Huang He, MD
role: STUDY_CHAIR
References: