Evaluation of a Standard Epidural Catheter During Clinical Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Frequency of paraesthesia during catheter insertion
Study Overview
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
Detailed Description
Study design
This study is a prospective, uncontrolled, open, non-randomised study ("Observational Study") with a CE-certified medical device.
Patients
Information and consent Information of the procedure and oral consent of epidural anaesthesia for the surgery is obtained as usual. Oral consent for data collection has to be obtained. No randomisation or blinding is performed and no non-standard procedures are necessary.
Inclusion criteria 100 patients scheduled for Epidural Anaesthesia will be included in this study. Eligible patients are ASA class I-III, between 18 and 75 years of age and are scheduled for EA, with or without general anaesthesia.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Frequency of paraesthesia during catheter insertion
Secondary Outcomes
No secondary outcomes reported