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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for Percutaneous Radiofrequency Ablation of Liver Tumors

Conditions
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Liver Tumor

Intervention / Treatment
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* Procedure: thoracic paravertebral blockade
* Procedure: local anaesthesia


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group PVB<br>standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.) | Procedure: thoracic paravertebral blockade<br>* Anesthesia was performed under the ultrasound guidance: the Th8 spinous process was identified, then a probe was moved lateral to medial until two adjacent transverse processes and the pleura were visible. After anaesthetising the skin with 2ml of 1% lignocaine (Lignocainum hydrochlorici, WZF 1%), the Touhy needle 22G (Smith Medical)was introduced under the real time guidance. Once in the paravertebral space, 20ml of 0,25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa Warsaw SA) was injected with an end point of a characteristic pleural displacement.<br>|
| Active Comparator: group BB<br>standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%). | Procedure: local anaesthesia<br>* Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of PVB on pain intensity | The level of pain will be assessed in all groups (PVB and BB) basing on the NRS scale (NRS 0- no pain, NRS 10 - the worst pain imaginable) Self reported pain intensity in 5 time points based on the numerical rating scale NRS (where 0 is no pain, 10 is the strongest pain). comparison of analgesic drug use in both groups | NRS during the procedure and 0,1,3,6,24 hours post surgery | 
| Effectiveness of PVB on pain intensity | The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption | 0,1,3,6,24 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' satisfaction | Patients' satisfaction will be assessed in all groups (PVB and BB) basing on a survey | 24 hours post surgery | 
| Surgeon's satisfaction | Surgeon's satisfaction will be assessed in all groups (PVB and BB) basing on a survey (where 0 is no satisfaction, 10-maximal satisfaction) | 0 h post surgery (immediately after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paravertebral block, Anaesthesia, Analgesia, regional anaesthesia, pain, patient satisfaction, patient comfort, operator satisfaction