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

Liver Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241887
• Other study ID #: UWarmiaMazury-2
• Status: Completed
• Phase: N/A
• Start date: September 9, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2020
• Source: University of Warmia and Mazury
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 31, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumor

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Anesthesiology and Intensive Care Clinical Ward, Clinical University Hospital	Olsztyn	Warmian-masurian

Sponsors (1)

Lead Sponsor	Collaborator
University of Warmia and Mazury

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patients' satisfaction	Patients' satisfaction will be assessed in all groups (PVB and BB) basing on a survey	24 hours post surgery
Secondary	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)