Clinical Trial

Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation

Active, Not Recruiting Phase 1/2
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Summary
Effective pain management during percutaneous thermal ablation of liver tumors outside the operating room remains a significant challenge. While hepatic hilar nerve block (HHNB) provides partial analgesia, its incomplete efficacy often requires opioid supplementation, potentially increasing perioperative risks. Esketamine, an N-methyl-D-aspartate receptor antagonist, exhibits unique dual analgesic-sedative properties that may address this therapeutic gap, thus obviating the necessity for opioids. This prospective dose-finding study aimed to establish the median effective dose (ED50) and 95% effective dose (ED95) of esketamine for opioid-free analgesia during ultrasound-guided thermal ablation of liver tumors under HHNB. Afterwards, the investigators will conduct an RCT study to evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-20; most recent amendment 2025-09-05.
Status change: Recruiting → Active, Not Recruiting 2025-06-29
Trial Details
NCT Number NCT07034950
Lead Sponsor The First Affiliated Hospital of Xiamen University
Conditions Hepatic Neoplasm, Hepatic Cancer
Enrollment 79 participants
Start Date 2025-06-29
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-11