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CMRA for US-guided-MWA of Liver Tumors

Combined Multiple Regional Anesthesia for Microwave Ablation of Liver Tumors

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05990257
Enrollment
122
Registered
2023-08-14
Start date
2018-07-01
Completion date
2023-12-31
Last updated
2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Tumors, Microwave Ablation, Pain Control, Regional Anesthesia

Brief summary

Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These patients were allocated into three groups based on tumor size and number: A, B, and C. Prior to the ablation procedure, Group A patients received a combination of hepatic hilar block (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA. Evaluative parameters included the Numerical Rating Scale (NRS) scores, consumption of morphine, incidence of complications, and factors influencing perioperative pain.

Detailed description

Patients with liver tumors who underwent US-guided-MWA of liver tumors were enrolled. These patients were allocated into three groups based on tumor size and number: A, B, and C. Prior to the ablation procedure, Group A patients received a combination of hepatic hilar block (HHB), Transversus abdominis plane block (TAPB), and local anesthesia (LA). Patients in Group B were administered HHB in conjunction with LA, while those in Group C received TAPB and LA.Pain levels were routinely assessed through the Numerical Rating Scale (NRS), with scores being recorded by the attending nurse every 15 minutes. The frequency of these assessments would be increased if the patient reported discomfort or if there were changes observed in vital signs. If a patient reported a pain level of ≥4 on the NRS scale, an intravenous dose of 10mg morphine was administered, provided that cardiopulmonary safety could be assured. The determination of cardiopulmonary safety was made by the interventional radiologist (M. L. with 20 years of experience). Following the ablation procedure, all patients were monitored for a period of 36 hours. During this period, several parameters were recorded at the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedure. These parameters included the NRS score, vital signs, any need for morphine, and the occurrence of any adverse events.

Interventions

PROCEDUREHHB+TAPB+and LA

Hepatic Hilar Block (HHB), Transversus Abdominis Plane Block (TAPB), and Local Anesthesia (LA)

PROCEDUREHHB+LA

Hepatic Hilar Block (HHB) and Local Anesthesia (LA)

PROCEDURETAPB+LA

Transversus Abdominis Plane Block (TAPB) and Local Anesthesia (LA)

Sponsors

Lu Wang
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
pain controlat the time of the procedure and again at 4, 8-, 12-, 24-, and 36-hours post-procedureNRS score was used to evaluate pain control

Countries

China

Contacts

Primary ContactLu Wang
656121781@qq.com15828016725

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026