Clinical trial NCT05416073: Effect of Esketamine on Abdominal Pain During TACE-HAIC in Patients With Hepatocellular Carcinoma
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 )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Transarterial Chemoembolization
Hepatic Arterial Infusion Chemotherapy
Pain
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum pain intensity in the first 3 hours of HAIC treatment
timeFrame: From the beginning of HAIC treatment to 3 hours after HAIC treatment
measure: Pain intensity at 1 hour after HAIC treatment
timeFrame: From the beginning of HAIC treatment to 1 hour after HAIC treatment
measure: Pain intensity at 2 hours after HAIC treatment
timeFrame: From 1 hour to 2 hours after HAIC treatment
measure: Pain intensity at 3 hours after HAIC treatment
timeFrame: From 2 hours to 3 hours after HAIC treatment
Secondary outcomes:
measure: Numbers of analgesic pump compressions
timeFrame: From the beginning of HAIC treatment to 48 hours after HAIC treatment
measure: Analgesic consumption
timeFrame: From the beginning of HAIC treatment to 48 hours after HAIC treatment
measure: Pain intensity at 8 hours after HAIC treatment
timeFrame: From 7 hours to 8 hours after HAIC treatment
measure: Pain intensity at 16 hours after HAIC treatment
timeFrame: From 15 hours to 16 hours after HAIC treatment
measure: Pain intensity at 24 hours after HAIC treatment
timeFrame: From 23 hours to 24 hours after HAIC treatment
measure: Pain intensity at 32 hours after HAIC treatment
timeFrame: From 31 hours to 32 hours after HAIC treatment
measure: Pain intensity at 40 hours after HAIC treatment
timeFrame: From 39 hours to 40 hours after HAIC treatment
measure: Pain intensity at 48 hours after HAIC treatment
timeFrame: From 47 hours to 48 hours after HAIC treatment
measure: Pain intensity on the seventh days after HAIC treatment
timeFrame: From 7 days to 8 days after HAIC treatment
measure: Pain intensity On the 14th day after HAIC treatment
timeFrame: From 13 days to 14 days after HAIC treatment
measure: Pain intensity on the 21st after HAIC treatment
timeFrame: From 20 days to 21 days after HAIC treatment
Other outcomes:
measure: Ramsay Sedation score at 1 hour after HAIC treatment
timeFrame: From the beginning of HAIC treatment to 1 hour after HAIC treatment
measure: Ramsay Sedation score at 2 hours after HAIC treatment
timeFrame: From 1 hour to 2 hours after HAIC treatment
measure: Ramsay Sedation score at 3 hours after HAIC treatment
timeFrame: From 2 hours to 3 hours after HAIC treatment
measure: Ramsay Sedation score at 8 hours after HAIC treatment
timeFrame: From 7 hours to 8 hours after HAIC treatment
measure: The quality of sleep on the fist day after HAIC treatment
timeFrame: From the ending of HAIC treatment to 1 day after HAIC treatment
measure: The quality of sleep on the second day after HAIC treatment
timeFrame: From 1 day to 2 days after HAIC treatment
measure: The quality of sleep on the third day after HAIC treatment
timeFrame: From 2 days to 3 days after HAIC treatment
measure: Adverse reaction
timeFrame: From the beginning of HAIC treatment to 72 hours after HAIC treatment
measure: Degree of satisfaction
timeFrame: From the beginning of HAIC treatment to 24 hours after HAIC treatment
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital, Chongqing Medical University
name: Huang He, MD
role: STUDY_CHAIR
affiliation: The Second Affiliated Hospital, Chongqing Medical University
name: Huang yan, MD
role: PRINCIPAL_INVESTIGATOR
References: