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临床试验/NCT01812577
NCT01812577已完成不适用

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

Campus Bio-Medico University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Intensity of postoperative pain after radiofrequency ablation of liver lesion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • written consent ASA I-III

排除标准

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

结局指标

主要结局

Intensity of postoperative pain after radiofrequency ablation of liver lesion

时间窗: 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.

次要结局

  • Consumption of post-operative opioid(Within 24 post-operative hours)
  • Incidence of complications(From procedure to 24 hours)

研究者

发起方
Campus Bio-Medico University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimiliano Carassiti

MD

Campus Bio-Medico University

研究点 (1)

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