Hepatocellular CarcinomaPhase 4TACE-HAICNCT05416073
Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma
A Phase 4 study testing Esketamine and Sufentanil in people with Hepatocellular Carcinoma and Transarterial Chemoembolization, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Previous studies have confirmed that limb pain caused by oxaliplatin chemotherapy is related to spinal cord central sensitization - induced hyperalgesia through oxaliplatin activating spinal cord NMDA receptor(N-methyl-D-aspartic acid receptor). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Transarterial Chemoembolization, Hepatic Arterial Infusion Chemotherapy
- 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
- 70 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2022to 30 Apr 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
- Participate in this study and sign informed consent
- Voluntarily receive postoperative intravenous controlled analgesia
- Patients receiving TACE-HAIC treatment
- HCC (hepatocellular carcinoma)patients with primary liver cancer BCLC(Barcelona Clinic Liver Cancer) stage B and C, liver function A
- Age 18 to 80
Who cannot join
- Patients who were unable to cooperate or refused to participate in the trial
- Pregnant women
- Patients with sensory abnormalities such as diabetes neuropathy
- 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
Show all 11Show fewer
- 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
- Can not follow with the study procedure
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
Guangyou Duan, MD, (+86)18323376014, duangy@hospital.cqmu.edu.cn
About this study
Official title: Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma: a Prospective Study TACE-HAIC (Transcatheter Arterial Chemoembolization Combined With Hepatic Artery Infusion Chemotherapy )
Previous studies have confirmed that limb pain caused by oxaliplatin chemotherapy is related to spinal cord central sensitization - induced hyperalgesia through oxaliplatin activating spinal cord NMDA receptor(N-methyl-D-aspartic acid receptor). The investigators speculate that this may be the same as the mechanism of severe abdominal pain caused by HAIC(Hepatic Artery Infusion Chemotherapy) during oxaliplatin infusion. The analgesic effect of Esketamine is mainly related to its inhibition of NMDA receptor in spinal cord. Therefore, this study hypothesized that Esketamine can inhibit the sensitization of spinal cord center by inhibiting NMDA receptor, so as to alleviate severe abdominal pain during HAIC perfusion, and reduce abdominal pain caused by ischemia and inflammation by TACE(transcatheter arterial chemoembolization) by improving organ perfusion and anti-inflammatory effect, Therefore, it is expected that Esketamine can better alleviate acute severe abdominal pain caused by TACE-HAIC (transcatheter arterial chemoembolization combined with Hepatic Artery Infusion Chemotherapy )treatment than sufentanil, decrease the dosage of opioids, and reduce the incidence and degree of chronic abdominal pain after treatment.
- Conditions
- Hepatocellular Carcinoma, Transarterial Chemoembolization, Hepatic Arterial Infusion Chemotherapy, Pain
- 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. After that, the intravenous analgesia pump was started. 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. After that, the intravenous analgesia pump was started. 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.
Maximum pain intensity in the first 3 hours of HAIC treatment
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 HAIC treatment to 3 hours after HAIC treatment
Pain intensity at 1 hour after HAIC treatment
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 HAIC treatment to 1 hour after HAIC treatment
Pain intensity at 2 hours after HAIC treatment
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 1 hour to 2 hours after HAIC treatment
Pain intensity at 3 hours after HAIC treatment
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 2 hours to 3 hours after HAIC treatment
Secondary outcomes (11)
Numbers of analgesic pump compressions
When the patients felt pain, the patient controlled analgesia pump can be pressed once
Measured: From the beginning of HAIC treatment to 48 hours after HAIC treatment
Analgesic consumption
Analgesic consumption is assessed by the total amount of pain remedy with dolantin when the analgesic effect is poor after pressing analgesic pump for 3 times or more
Measured: From the beginning of HAIC treatment to 48 hours after HAIC treatment
Pain intensity at 8 hours after HAIC treatment
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 7 hours to 8 hours after HAIC treatment
Pain intensity at 16 hours after HAIC treatment
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 15 hours to 16 hours after HAIC treatment
Pain intensity at 24 hours after HAIC treatment
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 23 hours to 24 hours after HAIC treatment
Pain intensity at 32 hours after HAIC treatment
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 31 hours to 32 hours after HAIC treatment
Pain intensity at 40 hours after HAIC treatment
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 39 hours to 40 hours after HAIC treatment
Pain intensity at 48 hours after HAIC treatment
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 47 hours to 48 hours after HAIC treatment
Pain intensity on the seventh days after HAIC treatment
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 7 days to 8 days after HAIC treatment
Pain intensity On the 14th day after HAIC treatment
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 13 days to 14 days after HAIC treatment
Pain intensity on the 21st after HAIC treatment
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 20 days to 21 days after HAIC treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start22 Jun 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 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
- 70 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 UniversityHuang yan, MD, Principal investigator, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416073
- Sponsor's protocol ID
- pain during TACE-HAIC
- Acronym
- TACE-HAIC
- Status last verified
- Jun 2022
- First submitted
- 20 May 2022
- Last updated
- 24 Feb 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 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma: a Prospective Study TACE-HAIC (Transcatheter Arterial Chemoembolization Combined With Hepatic Artery Infusion Chemotherapy )
- ClinicalTrials.gov ID
- NCT05416073
- Acronym / sponsor ID
- TACE-HAIC / pain during TACE-HAIC
- Conditions
- Hepatocellular Carcinoma, Transarterial Chemoembolization, Hepatic Arterial Infusion Chemotherapy, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 13 Jun 2022 (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.
Previous studies have confirmed that limb pain caused by oxaliplatin chemotherapy is related to spinal cord central sensitization - induced hyperalgesia through oxaliplatin activating spinal cord NMDA receptor(N-methyl-D-aspartic acid receptor). The investigators speculate that this may be the same as the mechanism of severe abdominal pain caused by HAIC(Hepatic Artery Infusion Chemotherapy) during oxaliplatin infusion. The analgesic effect of Esketamine is mainly related to its inhibition of NMDA receptor in spinal cord. Therefore, this study hypothesized that Esketamine can inhibit the sensitization of spinal cord center by inhibiting NMDA receptor, so as to alleviate severe abdominal pain during HAIC perfusion, and reduce abdominal pain caused by ischemia and inflammation by TACE(transcatheter arterial chemoembolization) by improving organ perfusion and anti-inflammatory effect, Therefore, it is expected that Esketamine can better alleviate acute severe abdominal pain caused by TACE-HAIC (transcatheter arterial chemoembolization combined with Hepatic Artery Infusion Chemotherapy )treatment than sufentanil, decrease the dosage of opioids, and reduce the incidence and degree of chronic abdominal pain after treatment.
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)
- Participate in this study and sign informed consent
- Voluntarily receive postoperative intravenous controlled analgesia
- Patients receiving TACE-HAIC treatment
- HCC (hepatocellular carcinoma)patients with primary liver cancer BCLC(Barcelona Clinic Liver Cancer) stage B and C, liver function A
- Age 18 to 80
Key exclusion criteria (11 listed)
- Patients who were unable to cooperate or refused to participate in the trial
- Pregnant women
- Patients with sensory abnormalities such as diabetes neuropathy
- 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)
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. After that, the intravenous analgesia pump was started. 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. After that, the intravenous analgesia pump was started. 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
Maximum pain intensity in the first 3 hours of HAIC treatment
Time frame: From the beginning of HAIC treatment to 3 hours after HAIC treatment
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 1 hour after HAIC treatment
Time frame: From the beginning of HAIC treatment to 1 hour after HAIC treatment
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 2 hours after HAIC treatment
Time frame: From 1 hour to 2 hours after HAIC treatment
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 3 hours after HAIC treatment
Time frame: From 2 hours to 3 hours after HAIC treatment
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)
11 secondary outcomes
Numbers of analgesic pump compressions
Time frame: From the beginning of HAIC treatment to 48 hours after HAIC treatment
Analgesic consumption
Time frame: From the beginning of HAIC treatment to 48 hours after HAIC treatment
Pain intensity at 8 hours after HAIC treatment
Time frame: From 7 hours to 8 hours after HAIC treatment
Pain intensity at 16 hours after HAIC treatment
Time frame: From 15 hours to 16 hours after HAIC treatment
Pain intensity at 24 hours after HAIC treatment
Time frame: From 23 hours to 24 hours after HAIC treatment
Pain intensity at 32 hours after HAIC treatment
Time frame: From 31 hours to 32 hours after HAIC treatment
Pain intensity at 40 hours after HAIC treatment
Time frame: From 39 hours to 40 hours after HAIC treatment
Pain intensity at 48 hours after HAIC treatment
Time frame: From 47 hours to 48 hours after HAIC treatment
Pain intensity on the seventh days after HAIC treatment
Time frame: From 7 days to 8 days after HAIC treatment
Pain intensity On the 14th day after HAIC treatment
Time frame: From 13 days to 14 days after HAIC treatment
Pain intensity on the 21st after HAIC treatment
Time frame: From 20 days to 21 days after HAIC treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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
Huang yan, MD principal investigator
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 Transarterial 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 11 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 24 Feb 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?
Maximum pain intensity in the first 3 hours of HAIC treatment (time frame: From the beginning of HAIC treatment to 3 hours after HAIC treatment). The study lists 4 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 24 Feb 2023.