Evaluation of a Standard Epidural Catheter During Clinical Practice - Full Text View

Sponsored by:	Maastricht University Medical Center
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00396903

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

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

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 Medical Center

Investigators

Principal Investigator:

Marco Marcus, MD, PhD

Maastricht University Medical Center

More Information

Publications of Results:

Bouman EA, Gramke HF, Wetzel N, Vanderbroeck TH, Bruinsma R, Theunissen M, Kerkkamp HE, Marcus MA. Evaluation of two different epidural catheters in clinical practice. narrowing down the incidence of paresthesia! Acta Anaesthesiol Belg. 2007;58(2):101-5.

Study ID Numbers:	O-H-0403
Study First Received:	November 7, 2006
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00396903
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.

Study placed in the following topic categories:

Paresthesia

ClinicalTrials.gov processed this record on January 14, 2009