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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
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief 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

Condition or disease Intervention/treatment
Patients Scheduled for Epidural Anaesthesia Device: catheter

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Evaluation of a Standard Epidural Catheter During Clinical Practice
Study Start Date : April 2003
Study Completion Date : November 2005



Primary Outcome Measures :
  1. Frequency of paraesthesia during catheter insertion


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for Epidural Anaesthesia
  • ASA class I-III
  • between 18 and 75

Exclusion Criteria:

  • contraindications for epidural anaesthesia
  • Non-competent and non-cooperative
  • pregnant and breast-feeding women
  • medicament- and drug abuse or problems in communication
  • participating in parallel in another clinical study with experimental drugs or devices

Information from the National Library of Medicine

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


Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Marco Marcus, MD, PhD Maastricht University Medical Center

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00396903     History of Changes
Other Study ID Numbers: O-H-0403
First Posted: November 8, 2006    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by Maastricht University Medical Center:
Anaesthetic techniques
epidural catheters
paraesthesia
side effects.