Using ultrasound-guided microwave ablation for liver tumors with regional anesthesia techniques
Combined Multiple Regional Anesthesia for Microwave Ablation of Liver Tumors
This study tests different ways to manage pain for patients with liver tumors undergoing a specific treatment called microwave ablation to see which method helps them feel more comfortable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sichuan Cancer Hospital and Research Institute Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT05990257 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of different regional anesthesia techniques in patients undergoing ultrasound-guided microwave ablation (MWA) for liver tumors. Patients are divided into three groups based on tumor size and number, receiving varying combinations of hepatic hilar block, transversus abdominis plane block, and local anesthesia prior to the procedure. Pain levels are assessed using the Numerical Rating Scale, and morphine consumption is monitored to evaluate pain control and any complications during the perioperative period. The study aims to determine the optimal anesthesia approach to enhance patient comfort during and after the ablation procedure.
Who should consider this trial
Good fit: Ideal candidates include patients with primary hepatic carcinoma or hepatic metastases that meet specific size and number criteria, as well as those with symptomatic hepatic hemangiomas.
Not a fit: Patients with liver tumors that exhibit vascular invasion, biliary intrusion, or distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve pain management for patients undergoing liver tumor ablation.
How similar studies have performed: Other studies have shown promising results with similar regional anesthesia techniques in pain management during surgical procedures, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Primary hepatic carcinoma was considered if characterized by a solitary tumor (≤5cm in maximum diameter) or by the presence of multiple tumors (2-3 in number, each ≤3cm in maximum diameter). Importantly, these tumors were required to be devoid of vascular invasion, biliary intrusion, contiguous organ invasion, or any evidence of distant metastasis. Another group included in the study were patients with hepatic metastases, limited to no more than 5 tumors each measuring ≤3cm in maximum diameter. Furthermore, patients with hepatic hemangioma were also considered for inclusion. Specific criteria applied in these cases included tumors larger than 5cm in maximum diameter that showed considerable growth (imaging findings suggest that the diameter of the tumor has increased by more than 1cm) in the preceding two years and were associated with persistent hemangioma-related abdominal pain or discomfort. Alternatively, tumors measuring up to 5cm in maximum diameter, exhibiting a pronounced growth propensity and located at the first, second, or third hilar region in close proximity to the hilar bile duct, portal vein, hepatic artery, hepatic vein, or inferior vena cava were also considered. And all these patients cannot tolerate surgery due to other organ damage or do not want to undergo surgical treatment. The ASA grade is II or III. Exclusion Criteria: Patients with severe underlying medical conditions that could potentially prevent them from tolerating the US-guided MWA procedure were ruled out. Those with tumors invading blood vessels, bile ducts, adjacent organs, or presenting with extrahepatic metastasis were also excluded. Further, any cases presenting with uncorrectable coagulation disorders, thrombocytopenia, or currently under administration of anticoagulant agents were deemed unfit for the study. Finally, patients were excluded if a safe trajectory for executing US-guided MWA was not feasible.
Where this trial is running
Chengdu, Sichuan
- Sichuan cancer hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Lu Wang
- Email: 656121781@qq.com
- Phone: 15828016725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.