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Evaluation of a Standard Epidural Catheter During Clinical Practice

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00396903
First received: November 7, 2006
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

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 Intervention
Patients Scheduled for Epidural Anaesthesia
Device: catheter

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of a Standard Epidural Catheter During Clinical Practice

Further study details as provided by Maastricht University Medical Center:

Estimated Enrollment: 100
Study Start Date: April 2003
Study Completion Date: November 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396903

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

Publications:
ClinicalTrials.gov Identifier: NCT00396903     History of Changes
Other Study ID Numbers: O-H-0403
Study First Received: November 7, 2006
Last Updated: December 19, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on November 24, 2014