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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain Intensity at 24hours after the beginning of TACE operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duan Guang you, MD | Contact | 18323376014 | +86 | duangy@hospital.cqmu.edu.cn |
| Wang Da gang, MD | Contact | 023 63693014 | +86 | kuanrenlunli@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Huang He, MD | The Second Affiliated Hospital, Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
The individual participant data for this study is available from the sponsor on reasonable request through email.
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Within one year
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| From 0 to 1hour after the beginning of TACE operation |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |