Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for PRFA of Liver Tumors

University of Warmia and Mazury

Status: Completed

Conditions: Liver Tumor

Treatments: Procedure: thoracic paravertebral blockade; Procedure: local anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04241887

UWarmiaMazury-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

group PVB

Experimental group

Description:

standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.)

Treatment:

Procedure: thoracic paravertebral blockade

group BB

Active Comparator group

Description:

standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%).

Treatment:

Procedure: local anaesthesia