Clinical trial NCT04241887: Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors
Official title: Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for Percutaneous Radiofrequency Ablation of Liver Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Tumor
Keywords: Paravertebral block
Anaesthesia
Analgesia
regional anaesthesia
pain
patient satisfaction
patient comfort
operator satisfaction
Lead sponsor: University of Warmia and Mazury
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 patients scheduled for an elective Percutaneus Radiofrequency Ablation (PRFA) of a hepatocellular carcinoma were enrolled in the study. Patients were divided in 2 groups:

* group PVB - 15 patients under paravertebral block anaesthesia
* group BB - 15 patients under local anesthesia, without paravertebral block.
Primary purpose: TREATMENT

Brief summary: Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the periooperative setting. In order to facilitate tumor access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious.

This study aims to assess the impact of a single shot thoracic paravertebral block (TPVB) on a patient's haemodynamic stability, patient's and operator's comfort and satisfaction during the operation and analgesia in the post-operative period.

Detailed description: High temperatures used during the percutaneus radiofrequency ablation (PRFA) of liver tumors can cause acute pain in the perioperative setting. In order to facilitate tumor exposure and access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. It is mandatory to provide an adequate acute postoperative pain control for our patients.

This prospective randomized, single center study was approved by the Bioethics Committee at the University of Warmia and Mazury in Olsztyn, (Poland) under the resolution No. 46/2017.

Eligibility criteria: Inclusion Criteria:

* patients with primary liver tumor (HCC)
* patient scheduled for an elective surgery
* tumor diameter) \<5 cm two tumors \<3cm
* Age \>18 years
* Physical State 1,2 or 3 of the American Society of Anesthesiology (ASA)

Exclusion Criteria:

* ASA IV and V
* Thrombocytopenia (\<40x10 \^ 9 / L)
* Severe cirrhosis (Child-Pugh C classification)
* History of psychiatric/cognitive disease
* Patients who do not give informed consent
* Patients with contraindications or history of hypersensitivity to local anaesthesia drugs
* History of chronic pain, chronic opioid use (\> 3 months)

Primary outcomes:
measure: Effectiveness of PVB on pain intensity
timeFrame: NRS during the procedure and 0,1,3,6,24 hours post surgery
measure: Effectiveness of PVB on pain intensity
timeFrame: 0,1,3,6,24 hours post surgery
Secondary outcomes:
measure: Patients' satisfaction
timeFrame: 24 hours post surgery
measure: Surgeon's satisfaction
timeFrame: 0 h post surgery (immediately after surgery)
Other outcomes:
Locations:
city: Olsztyn
country: Poland
facility: Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital
state: Warmian-masurian
Study officials:
affiliation: University of Warmia and Mazury Faculty of Medicine (University Hospital)
name: Ewa Mayzner-Zawadzka, PhD
role: STUDY_CHAIR
References: