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Evaluation of a Standard Epidural Catheter During Clinical Practice

NCT00396903 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2015-04-08

No results posted yet for this study

Summary

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

Conditions

  • Patients Scheduled for Epidural Anaesthesia

Interventions

DEVICE

catheter

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Marco Marcus, MD, PhD · Maastricht University Medical Center

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Completion
2005-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00396903 on ClinicalTrials.gov