Evaluation of a Standard Epidural Catheter During Clinical Practice

NCT00396903 | Completed

• 1 other identifier: O-H-0403
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Patients Scheduled for Epidural Anaesthesia

Keywords

Anaesthetic techniques; epidural catheters; paraesthesia; side effects.

Outcome Measures

Primary Outcomes (1)

• Frequency of paraesthesia during catheter insertion

Interventions

catheter DEVICE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 17710897 RESULT

MeSH Terms

Conditions

Paresthesia

Interventions

Catheters

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Marco Marcus, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 8, 2006
• Study Start: April 1, 2003
• Study Completion: November 1, 2005
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

NL (1)