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

NCT ID: NCT04241887

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-09
• Study Completion Date: 2019-08-31

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.

Conditions

Liver Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group PVB

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

Group Type: EXPERIMENTAL

thoracic paravertebral blockade

Intervention Type: PROCEDURE

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.

group BB

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

Group Type: ACTIVE_COMPARATOR

local anaesthesia

Intervention Type: PROCEDURE

Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.

Interventions

thoracic paravertebral blockade

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.

Intervention Type: PROCEDURE

local anaesthesia

Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Warmia and Mazury

OTHER

Sponsor Role: lead

Responsible Party

Malgorzata Braczkowska

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ewa Mayzner-Zawadzka, PhD

Role: STUDY_CHAIR

University of Warmia and Mazury Faculty of Medicine (University Hospital)

Locations

Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital

Olsztyn, Warmian-Masurian Voivodeship, Poland

Countries

Poland

Other Identifiers

UWarmiaMazury-2

Identifier Type: -

Identifier Source: org_study_id