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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Tumor
• Intervention / Treatment: Procedure: thoracic paravertebral blockade; Procedure: local anaesthesia

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warmian-masurian
    • Olsztyn, Warmian-masurian, Poland, 11-041
      • Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group PVB; standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.)	Procedure: 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.
Active Comparator: group BB; standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%).	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Warmia and Mazury
• Investigators: Study Chair: Ewa Mayzner-Zawadzka, PhD, University of Warmia and Mazury Faculty of Medicine (University Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2017
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: pain; Analgesia; Anaesthesia; patient satisfaction; regional anaesthesia; patient comfort; Paravertebral block; operator satisfaction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: UWarmiaMazury-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study participants data for all primary and secondary outcome measures
• IPD Sharing Time Frame: Data will be available within 12 months of study completion
• IPD Sharing Access Criteria: Data will be made available for researchers who provide a methodologically sound proposal. Proposals should be directed to m.braczkowska@gmail.com . Data access requests will be reviewed by an External Independent Review Panel. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No