Clinical Trials Directory

Trials / Completed

CompletedNCT01812577

Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions

Evaluation of the Analgesic Efficacy of the Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Campus Bio-Medico University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and after the procedure. During the procedure patients need deep sedation and cannot be collaborative. Furthermore post-operative analgesia is necessary. The aim of this study is to evaluate if the ultrasound-guided paravertebral block (TPVB)with a single injection can provide anesthesia and post-operative analgesia in these patients.

Detailed description

The purpose of this study is to evaluate if single injection TPVB, ultrasound guided, ENS assisted, is advantageous compared to deep sedation (DS)in patients undergoing percutaneous radiofrequency ablation of liver lesions with respect to post-operative analgesia (at rest and in movement)and vomiting. Furthermore we collect data on operator and patient satisfaction. In this study patients are randomly divided into two groups (20 patient each): TPVB and DS. In TPVB group the block is performed in lateral position at level of T7 with bupivacaine 5mg/ml. In DS group the procedure is conducted under local and intravenous anesthesia, and a post-operative analgesia is assigned. Data on patient, on procedures (duration, number and position of lesions etc.), complications with the anesthesiological technique are collected. The intensity of post-operative pain is assessed at 3-6-12 and 24 hours after procedure in both group using VRS pain scale at rest and in movement. Any concomitant event like nausea, vomiting, respiratory complications etc are recorded.

Conditions

Timeline

Start date
2012-12-01
Primary completion
2013-12-01
Completion
2022-09-01
First posted
2013-03-18
Last updated
2024-08-23

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01812577. Inclusion in this directory is not an endorsement.