Evaluation of a Standard Epidural Catheter During Clinical Practice

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.

Exclusion criteria

Anamnestic exclusion criteria are all contraindications for epidural anaesthesia (e.g. neurological deficit, skin infection of the puncture site, diseases leading to neurological impairment such as diabetes, coagulation impairment). Non-competent and non-cooperative patients as well as pregnant and breast-feeding women are also to be excluded. Same applies for patients with medicament- and drug abuse or problems in communication or those participating in parallel in another clinical study with experimental drugs or devices.

Randomisation and Blinding No randomization is required. An independent observer who is not performing the epidural will record occurrence, incidence and intensity of paraesthesia.

Definition of the main and the secondary criteria

Main criteria

• Frequency of paraesthesia during catheter insertion

Secondary criteria

• Frequency of inadvertent venous cannulation (aspiration of blood)
• Intensity of paraesthesia (VAS)

• description: - pain
• electric shock
• burning sensation
• shooting effect
• motor reactions (right/left)
• discomfort
• others
• Frequency and kind of difficulties during insertion of the catheter (rating of "easiness of insertion": 0 = no resistance, 1 = minor difficulties, 2 = serious difficulties, 3 = impossible)
• Facultative: Documentation of paraesthesia/difficulties during catheter removal at 48 hours after surgery (or earlier, if appropriate)

Concomitant parameters

• Patient data (age, height, weight, sex, diagnosis, kind of intervention, ASA class, relevant co-diagnosis, relevant co-medication)
• Epidural anaesthesia and -analgesia related data

• Data that relate to the description of the puncture process and method chosen in case of difficulties during puncture, catheter insertion and removal
• Level of sensory blockade
• Indwelling time of epidural catheter by recording the time of insertion
• Dose/kind of anaesthetic used for epidural anaesthesia, type of general anaesthesia if relevant
• Kind of analgesia done by epidural catheter
• Adequacy of epidural anaesthesia (yes / no)
• Further complications/side effects related to epidural anaesthesia/analgesia (i.e. dural puncture, haematoma, etc)
• Judgement of the anaesthesiologist concerning handling features (0 = no resistance, 1 = minor difficulties, 2 = serious difficulties)
• Catheter damages

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