Hepatocellular CarcinomaPhase 4NCT05670561
Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma
A Phase 4 study testing Esketamine and Sufentanil in people with Hepatocellular Carcinoma and Transcatheter Arterial Chemoembolization, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Pain
- What is being tested?
- Esketamine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2023to 30 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Patients with hyperthyroidism without treatment or insufficient treatment
- Patients with severe respiratory dysfunction
- Allergy or existing contraindication to chemotherapeutic drugs, opioids or ketamine drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Duan Guangyou, MD, 18323376014 ext. +86, duangy@hospital.cqmu.edu.cn
About this study
Official title: Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma:a Prospective Study TACE(Transcatheter Arterial Chemoembolization)
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.
- Being tested
- Esketamine, Sufentanil
- Medical subject headings
- Carcinoma, Hepatocellular, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called patient controlled intravenous analgesia
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.
SufentanilDrug
Also called patient controlled intravenous analgesia
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: From 8hours to 12hours after the beginning of TACE operation
Secondary outcomes (10)
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)
Measured: From 12hours to 18hours after the beginning of TACE operation
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: From 0 to 48 hours after the beginning of TACE operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start5 Jan 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang He, MD, Study chair, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670561
- Sponsor's protocol ID
- pain after TACE
- Status last verified
- Feb 2023
- First submitted
- 2 Jan 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma:a Prospective Study TACE(Transcatheter Arterial Chemoembolization)
- ClinicalTrials.gov ID
- NCT05670561
- Acronym / sponsor ID
- pain after TACE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine-PCIA(patient controlled intravenous analgesia) | Experimental | Drug: EsketaminePCIA formula#100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline. |
| Sufentanil-PCIA(patient controlled intravenous analgesia) | Active comparator | Drug: SufentanilPCIA formula#100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineAlso: patient controlled intravenous analgesiaPCIA 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. | Drug | Esketamine-PCIA(patient controlled intravenous analgesia) |
| SufentanilAlso: patient controlled intravenous analgesiaPCIA 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. | Drug | Sufentanil-PCIA(patient controlled intravenous analgesia) |
Primary outcome
Pain Intensity at 4hours after the beginning of TACE operation
Time frame: From 0 to 4hours after the beginning of TACE
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)
Pain Intensity at 8hours after the beginning of TACE operation
Time frame: From 4hours to 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)
Pain Intensity at 12hours after the beginning of TACE operation
Time frame: From 8hours to 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)
10 secondary outcomes
Pain Intensity at 18hours after the beginning of TACE operation
Time frame: From 12hours to 18hours after the beginning of TACE operation
Pain Intensity at 24hours after the beginning of TACE operation
Time frame: From 18hours to 24hours after the beginning of TACE operation
Pain Intensity at 30hours after the beginning of TACE operation
Time frame: From 24hours to 30hours after the beginning of TACE operation
Pain Intensity at 36hours after the beginning of TACE operation
Time frame: From 30hours to 36hours after the beginning of TACE operation
Pain Intensity at 42hours after the beginning of TACE operation
Time frame: From 36hours to 42hours after the beginning of TACE operation
Pain Intensity at 48hours after the beginning of TACE operation
Time frame: From 42hours to 48hours after the beginning of TACE operation
Maximum Pain Intensity in the First 4hours after the beginning of TACE operation
Time frame: 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
Time frame: From 4hours to 8hours after the beginning of TACE operation
Maximum Pain Intensity in the Third 4hours after the beginning of TACE operation
Time frame: From 8hours to 12hours after the beginning of TACE operation
Analgesic Consumption
Time frame: From 0 to 48 hours after the beginning of TACE operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang He, MD study chair
The Second Affiliated Hospital, Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine and Sufentanil in people with Hepatocellular Carcinoma and Transcatheter Arterial Chemoembolization, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duan Guang you, MD (18323376014 ext. +86, duangy@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity at 4hours after the beginning of TACE operation (time frame: From 0 to 4hours after the beginning of TACE). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.