Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions

Completed

• Conditions: Liver Tumor

• Registration Number: NCT01812577
• Lead Sponsor: Campus Bio-Medico University

Brief 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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-18
• Primary Completion: 2013-12
• Study Completion: 2022-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• written consent ASA I-III

Exclusion Criteria

• allergy to local anesthetic infection in the site of planned injection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensity of postoperative pain after radiofrequency ablation of liver lesion	first 24 post-operative hours	Intensity of postoperative pain after radiofrequency ablation of liver lesion is evaluated in both groups using VRS of pain at rest and in movement after 3-6-12-24 hours from procedure.

Secondary Outcome Measures

Name	Time	Method
Consumption of post-operative opioid	Within 24 post-operative hours	We evaluate if there is differences in consumption of opioid in the two groups
Incidence of complications	From procedure to 24 hours	We record immediate complication such as PNX, vascular puncture etc, and post-operative complications such as nausea, vomiting, hypotension, etc, in both groups

Trial Locations

Locations (1)

Campus Bio-Medico; 🇮🇹 Rome, Italy/RM, Italy