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Completed

NCT Number: NCT01812577

Paravertebral Block for Percutaneous Radiofrequency Ablation of Liver Lesions

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.

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Key information

Conditions

Liver Tumor Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Campus Bio-Medico

Rome, Italy/RM, 00121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • written consent ASA I-III

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Intensity of postoperative pain after radiofrequency ablation of liver lesion

    Time frame: 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 outcomes

  1. Incidence of complications

    Time frame: 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

  2. Consumption of post-operative opioid

    Time frame: Within 24 post-operative hours

    We evaluate if there is differences in consumption of opioid in the two groups

Other outcomes

  1. Satisfaction of patient and of the operator

    Time frame: From the procedure to 24 hours later.

    We collect data on operator satisfaction during the procedure, and patients satisfaction at 24 hours after procedure

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Acronym: TPVB

Important dates

Study start
2012
Primary completion
2013
Study completion
2022
First posted
Mar 18, 2013
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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