Safety of Two Epidural Catheters in Thoracic Epidural Anaesthesia (TEA)
Condition: Anesthesia, Epidural; Paraesthesia
MeSH terms: Paresthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      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
    

Detailed description: 
      Epidural anaesthesia is a central neuraxial block technique with many applications.
      Improvements in equipment, drugs and technique have made it a popular and versatile
      anaesthetic technique, with applications in surgery, obstetrics and pain control. Both single
      injection and catheter techniques can be used. Its versatility means it can be used as an
      anaesthetic, as an analgesic adjuvant to general anaesthesia, and for postoperative analgesia
      in procedures involving the lower limbs, perineum, pelvis, abdomen and thorax.

      Although epidural anaesthesia is a safe technique, during the insertion of epidural catheters
      several side effects may occur, including transient paraesthesia and inadvertent vascular
      cannulation.

      Reported incidences for paraesthesia vary widely between about 0.2% and 50% in different
      articles, depending on the catheter (catheter material, soft-tipped or firm-tipped catheter),
      the applied technique (lumbar or thoracic epidural anaesthesia, depth of catheter insertion),
      the approach (midline or paramedian) and the included patients (obstetrical or
      non-obstetrical). Paraesthesias are not supposed to lead to permanent neurological sequelae,
      but are unpleasant and perturbing sensations for the patient.

      Besides inadvertent intrathecal location of the catheter, further problems include technical
      difficulties during threading or removal of the catheter. Here, the catheter shaft material
      seems to be the crucial factor for the incidence of problems.

      Based upon years of experience, a wide range of epidural catheters were created, among them
      the Perifix catheter of B. Braun. Common features are their high tensile strength and stretch
      resistance, excellent shaft stability with easy visualisation of blood or spinal fluid due to
      the crystal clear material, no risk of forming loops or knots, and softening of catheter
      within a few hours due to water absorption of the polyamide material.

      Recently, B. Braun Melsungen AG has developed a new generation of Perifix epidural catheters,
      which are already CE-labeled. These new catheters are different in their composition compared
      to the current Perifix Standard catheter with regard to the catheter material and tip
      configuration. They have an outer poly-urethane liner and an inner polyamide body.
      Experimental tests have shown that the positive features (e.g. pushability, kink resistance,
      gliding, withdrawal) of the Perifix Standard catheter can be maintained. Due to the
      polyurethane outer layer, the catheter gets softer when reaching body temperature immediately
      upon insertion. Based on this, it is expected that paraesthesias during catheter injection
      can be reduced by at least 20%.
    

Intervention name(s): Perifix Epidural Anaesthesia Catheter; Perifix Standard; Perifix New
Intervention type(s): Device; Device; Device
Intervention description(s): Epidural Catheter; Perifix Standard; Perifix New
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anaesthetic techniques; epidural; catheters; paraesthesia; side effects; Anesthesia, Epidural [E03.155.086.131]