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

Pain Clinical Trial

Official title:

Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma:a Prospective Study TACE(Transcatheter Arterial Chemoembolization)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670561
• Other study ID #: pain after TACE
• Status: Recruiting
• Phase: Phase 4
• Start date: January 5, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: February 2023
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Duan Guang you, MD
• Phone: 18323376014
• Email: duangy[@]hospital.cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdomen, Acute
• Abdominal Pain
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Pain
• Transcatheter Arterial Chemoembolization

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ramsay Sedation Score at 1 hour after the beginning of TACE operation	Grade 1 (soberness- the patient is anxious, uneasy or irritable)# Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)# Grade 3 (soberness- the patient only responds to commands)# Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)# Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.	From 0 to 1hour after the beginning of TACE operation
Other	Ramsay Sedation Score at 2 hours after the beginning of TACE operation	Grade 1 (soberness- the patient is anxious, uneasy or irritable)# Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)# Grade 3 (soberness- the patient only responds to commands)# Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)# Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.	From 1hour to 2hours after the beginning of TACE operation
Other	Ramsay Sedation Score at 3 hours after the beginning of TACE operation	Grade 1 (soberness- the patient is anxious, uneasy or irritable)# Grade 2 (soberness- the patient is cooperative, has good orientation or is quiet)# Grade 3 (soberness- the patient only responds to commands)# Grade 4 (sleep-the patient responds quickly to light tapping between eyebrows or strong sound stimulation)# Grade 5 (sleep-the patient responds slowly to light tapping between the eyebrows or strong sound stimulation) and Grade 6 (sleep-the patient has no response to light tapping between eyebrows or strong sound stimulation). Grade 1 indicates no sedation ; Grade 2 and 3 indicate good sedation ; Grade 4 to 6 indicate poor sedation.	From 2hours to 3hours after the beginning of TACE operation
Other	The Quality of Sleep on the Day Just before TACE Treatment	The Richards-Campbell Sleep Questionnaire (RCSQ) is assessed by the quality of patients' sleep quality.0~25 points indicate poor sleep quality;76~100 points indicate good sleep quality (0-100, 0 represents the worst sleep quality; 100 represents the best sleep quality ;higher scores mean a better outcome)	From the day just before TACE treatment to the operation day
Other	The Quality of Sleep on the Operation Day	The Richards-Campbell Sleep Questionnaire (RCSQ) is assessed by the quality of patients' sleep quality.0~25 points indicate poor sleep quality;76~100 points indicate good sleep quality (0-100, 0 represents the worst sleep quality; 100 represents the best sleep quality ;higher scores mean a better outcome)	From the operation day to first day after TACE treatment
Other	The Quality of Sleep on the First Day after TACE Treatment	The Richards-Campbell Sleep Questionnaire (RCSQ) is assessed by the quality of patients' sleep quality.0~25 points indicate poor sleep quality;76~100 points indicate good sleep quality (0-100, 0 represents the worst sleep quality; 100 represents the best sleep quality ;higher scores mean a better outcome)	From the first day after TACE treatment to the second day after TACE treatment
Other	Adverse Reaction	Adverse reaction is recorded according to follow-up visits after TACE treatment	From 0 to 48 hours after the beginning of TACE operation
Other	Degree of Satisfaction	Degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction;higher scores mean a better outcome)	From 0 to 24 hours after the beginning of TACE operation
Other	Quality-of-Life Assessment at the the beginning of TACE operation	Quality-of-life contains patients' quality of sleep,fatigue, spiritual well-being, and appetite.The scores were categorized as follows: 1,worst;2,bad;3, mild;4, normal;5,very good.	From the beginning of TACE operation to 0 hour after the beginning of TACE operation
Other	Quality-of-Life Assessment at 24hours after the beginning of TACE operation	Quality-of-life contains patients' quality of sleep,fatigue, spiritual well-being, and appetite.The scores were categorized as follows: 1,worst;2,bad;3, mild;4, normal;5,very good.	From 0 to 24 hours after the beginning of TACE operation
Primary	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
Primary	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
Primary	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	Pain Intensity at 18hours 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 12hours to 18hours after the beginning of TACE operation
Secondary	Pain Intensity at 24hours 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 18hours to 24hours after the beginning of TACE operation
Secondary	Pain Intensity at 30hours 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 24hours to 30hours after the beginning of TACE operation
Secondary	Pain Intensity at 36hours 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 30hours to 36hours after the beginning of TACE operation
Secondary	Pain Intensity at 42hours 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 36hours to 42hours after the beginning of TACE operation
Secondary	Pain Intensity at 48hours 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 42hours to 48hours after the beginning of TACE operation
Secondary	Maximum Pain Intensity in the First 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 the beginning of TACE operation to 4hours after the beginning of TACE operation
Secondary	Maximum Pain Intensity in the Second 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 4hours to 8hours after the beginning of TACE operation
Secondary	Maximum Pain Intensity in the Third 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 8hours to 12hours after the beginning of TACE operation
Secondary	Analgesic Consumption	Analgesic consumption is assessed by the total amount of pain remedy with dolantin when the analgesic effect is poor.	From 0 to 48 hours after the beginning of TACE operation