Paraesthesia clinical trials

Safety of Two Epidural Catheters in Thoracic Epidural Anaesthesia (TEA)

Primary Objective: The primary objective is to demonstrate that the safety of Perifix New is non-inferior to using Perifix Standard when applied for thoracic epidural anaesthesia. Primary Endpoint: Incidence of spontaneous paraesthesia during catheter insertion Secondary Objectives: The secondary objectives are to determine the safety and performance of the investigational product: frequency of inadvertent vascular cannulation, difficulties involved in insertion and removal of the catheter, other safety features and data for the evaluation of handling characteristics. Title: Randomised, prospective, single-blind, controlled, study on the safety of two epidural catheters in patients undergoing surgery under thoracic epidural anaesthesia Investigational Product: Perifix Epidural Anaesthesia Catheter Test Product: Perifix New Reference Product: Perifix Standard Number of Sites and Countries: 1 site in The Netherlands Indication: Thoracic epidural anaesthesia Study Design: Randomised, prospective, single-blind, controlled study in 1 study center, phase IV Perifix New and Perifix Standard meet all the appropriate provisions of the relevant legislation implementing European Directives (both have CE-marking). Study Duration: 2 year duration Study Start: March-April 2005 Sample Size: n = 2*70 patients