Clinical trial
Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma:a Prospective Study TACE(Transcatheter Arterial Chemoembolization)
Name
pain after TACE
Description
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.
Trial arms
Trial start
2023-01-05
Estimated PCD
2023-06-30
Trial end
2023-07-30
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Esketamine-PCIA(patient controlled intravenous analgesia)
Other names:
patient controlled intravenous analgesia
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.
Arms:
Sufentanil-PCIA(patient controlled intravenous analgesia)
Other names:
patient controlled intravenous analgesia
Size
60
Primary endpoint
Pain Intensity at 4hours after the beginning of TACE operation
From 0 to 4hours after the beginning of TACE
Pain Intensity at 8hours after the beginning of TACE operation
From 4hours to 8hours after the beginning of TACE operation
Pain Intensity at 12hours after the beginning of TACE operation
From 8hours to 12hours after the beginning of TACE operation
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-03-29
1 organization