NCT04241887

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Warmia and Mazury · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-09-09
• Primary completion: 2018-12-12
• Completion: 2019-08-31
• First posted: 2020-01-27
• Last updated: 2020-01-27

Locations

1 site across 1 country: Poland