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

Not Applicable

Completed

• Conditions: Liver Tumor
• Interventions: Procedure: thoracic paravertebral blockade; Procedure: local anaesthesia

• Registration Number: NCT04241887
• Lead Sponsor: University of Warmia and Mazury

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.

Study Timeline

• Study Start: 2017-09-09
• Primary Completion: 2018-12-12
• Study Completion: 2019-08-31
• Status Verified: 2020-01
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-22
• Last Update Submitted: 2020-01-22
• Study First Posted: 2020-01-27
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group PVB	thoracic paravertebral blockade	standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.)
group BB	local anaesthesia	standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%).

Primary Outcome Measures

Name	Time	Method
Effectiveness of PVB on pain intensity	0,1,3,6,24 hours post surgery	The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital; 🇵🇱 Olsztyn, Warmian-masurian, Poland