Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma

Pain Clinical Trial

— TACE-HAIC  

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 )

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416073
• Other study ID #: pain during TACE-HAIC
• Status: Recruiting
• Phase: Phase 4
• Start date: June 22, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2022
• 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Abdominal Pain
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Pain
• Transarterial 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. 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.
• 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. 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.

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 HAIC treatment	Ramsay Sedation score is assessed by: 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 the beginning of HAIC treatment to 1 hour after HAIC treatment
Other	Ramsay Sedation score at 2 hours after HAIC treatment	Ramsay Sedation score is assessed by: 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 1 hour to 2 hours after HAIC treatment
Other	Ramsay Sedation score at 3 hours after HAIC treatment	Ramsay Sedation score is assessed by: 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 2 hours to 3 hours after HAIC treatment
Other	Ramsay Sedation score at 8 hours after HAIC treatment	Ramsay Sedation score is assessed by: 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 7 hours to 8 hours after HAIC treatment
Other	The quality of sleep on the fist day after HAIC 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 ending of HAIC treatment to 1 day after HAIC treatment
Other	The quality of sleep on the second day after HAIC 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 1 day to 2 days after HAIC treatment
Other	The quality of sleep on the third day after HAIC 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 2 days to 3 days after HAIC treatment
Other	Adverse reaction	Adverse reaction is recorded according to follow-up visits after HAIC treatment	From the beginning of HAIC treatment to 72 hours after HAIC treatment
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 the beginning of HAIC treatment to 24 hours after HAIC treatment
Primary	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)	From the beginning of HAIC treatment to 3 hours after HAIC treatment
Primary	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)	From the beginning of HAIC treatment to 1 hour after HAIC treatment
Primary	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)	From 1 hour to 2 hours after HAIC treatment
Primary	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)	From 2 hours to 3 hours after HAIC treatment
Secondary	Numbers of analgesic pump compressions	When the patients felt pain, the patient controlled analgesia pump can be pressed once	From the beginning of HAIC treatment to 48 hours after HAIC treatment
Secondary	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	From the beginning of HAIC treatment to 48 hours after HAIC treatment
Secondary	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)	From 7 hours to 8 hours after HAIC treatment
Secondary	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)	From 15 hours to 16 hours after HAIC treatment
Secondary	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)	From 23 hours to 24 hours after HAIC treatment
Secondary	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)	From 31 hours to 32 hours after HAIC treatment
Secondary	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)	From 39 hours to 40 hours after HAIC treatment
Secondary	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)	From 47 hours to 48 hours after HAIC treatment
Secondary	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)	From 7 days to 8 days after HAIC treatment
Secondary	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)	From 13 days to 14 days after HAIC treatment
Secondary	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)	From 20 days to 21 days after HAIC treatment