Randomised, Prospective, Single-blind, Controlled Multicenter Study on the Safety of Two Epidural Catheters in Patients Undergoing Surgery Under Thoracic Epidural Anaesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- The primary end-point will be the incidence of spontaneous paraesthesia during catheter insertion in TEA-patients.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for thoracic epidural anaesthesia (TEA), with or without general anaesthesia.
- •American Society of Anesthesiologists (ASA) class I-III
- •Patients aged 18 and ≤ 75 years of age
排除标准
- •Anamnestic exclusion criteria are all contraindications for epidural anaesthesia.
- •Severe scoliosis, previous surgery on the spine, M. Bechterew disease
- •Non-competent and non-cooperative patients
- •Patients with medicament and drug abuse problems, problems in communication, participating in parallel in another clinical study with experimental drugs or devices, receiving prohibited concomitant therapies
结局指标
主要结局
The primary end-point will be the incidence of spontaneous paraesthesia during catheter insertion in TEA-patients.
时间窗: 1 hour
次要结局
- The frequency of inadvertent vascular cannulation(1 hour)
- Difficulties involved in insertion and removal of the catheter(1 week)
- Data on additional complications(1 week)
- Data for the evaluation of handling characteristics(1 week)