A Phase 4 interventional study of Perifix Epidural Anaesthesia Catheter and Perifix Standard in Anesthesia, Epidural and Paraesthesia, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-05-13.
Sponsored by Maastricht University Medical Center · Phase 4, Interventional, and Treatment
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
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%.
66 studies on the registry are indexed under Paresthesia; 14 are open to participants now.
This study's enrollment of 140 is above the median of 48 across 52 interventional studies indexed under Paresthesia.
Browse Paresthesia studies →Maastricht University Medical Center is the lead sponsor of 853 studies on the registry; 114 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Perifix Standard
Device: Perifix Epidural Anaesthesia Catheter · Device: Perifix Standard
Perifix New
Device: Perifix Epidural Anaesthesia Catheter · Device: Perifix New
Epidural Catheter
Perifix Standard
Perifix New
The primary end-point will be the incidence of spontaneous paraesthesia during catheter insertion in TEA-patients.
Time frame: 1 hour
The frequency of inadvertent vascular cannulation
Time frame: 1 hour
Difficulties involved in insertion and removal of the catheter
Time frame: 1 week
Data on additional complications
Time frame: 1 week
Data for the evaluation of handling characteristics
Time frame: 1 week
The record gives a start of Apr 2005, a primary completion of Mar 2008 and a completion of May 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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