Evaluation of a Standard Epidural Catheter During Clinical Practice
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|ClinicalTrials.gov Identifier: NCT00396903|
Recruitment Status : Completed
First Posted : November 8, 2006
Last Update Posted : April 8, 2015
During the insertion of epidural catheters several complications can occur, including transient paraesthesia and inadvertent venous 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 anesthesia, depth of catheter insertion), the approach (midline or paramedian) and the included patients (obstetrical or non-obstetrical). Furthermore, the inconsistent definition of "paraesthesia" makes it difficult to compare the results of different studies. Paraesthesia are not supposed to lead to permanent neurological sequelea, but are unpleasant and perturbing sensations for the patient.
For inadvertent venous cannulation during epidural catheter placement, incidences between 1% and 14% have been reported. As for the paraesthesia rate, catheter material, technique, approach and included patients are determinants for the incidence of vessel puncture.
Main objective of this study is to determine the incidence of paraesthesia with this catheter.
Secondary objectives are to record
- the frequency of inadvertent venous cannulation
- difficulties involved in insertion and removal of the catheter
- data on additional complications
- data for the evaluation of handling characteristics
|Condition or disease||Intervention/treatment|
|Patients Scheduled for Epidural Anaesthesia||Device: catheter|
Show Detailed Description
|Study Type :||Observational|
|Enrollment :||100 participants|
|Official Title:||Evaluation of a Standard Epidural Catheter During Clinical Practice|
|Study Start Date :||April 2003|
|Actual Study Completion Date :||November 2005|
- Frequency of paraesthesia during catheter insertion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396903
|University Hospital Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Marco Marcus, MD, PhD||Maastricht University Medical Center|