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Study on the Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation Under Hilar Nerve Blockade

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.

Status
active
Phase
Phase 1, Phase 2
Institution
The First Affiliated Hospital of Xiamen University
Principal investigator
Lijuan Yan
Start date
2025-06-29
End date
2028-06-30
Registry ID
NCT07034950

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Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.