About this trial
Objectives: To compare the safety and efficacy of nylon (polyamide) epidural catheter versus polyurethane epidural catheter in patients undergoing major orthopedic surgery under continuous epidural anesthesia.
Background: Continuous epidural anesthesia is the most common anesthetic technique used in orthopedic surgery. However, the use of epidural catheters is associated with complications. The insertion of the catheter may be associated with intravascular or intrathecal placement, nerve root irritation, paresthesia, kinking, hematoma, or breakage during catheter removal.
Patients and Methods: This was a prospective, randomized, double-blind clinical trial; carried out on 60 patients undergoing major orthopedic surgery under continuous epidural anesthesia. Patients were randomly allocated into two equal groups; group N, using Nylon catheter, and group P, using Polyurethane catheter.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status ≤ II
Age from 21 to 60 years
Body Mass Index (BMI) < 35
Disqualifiers
American Society of Anesthesiologists (ASA) physical status > II
Age < 21 years or > 60 years
Body Mass Index (BMI) ≥ 35
Contraindications to regional anesthesia (including coagulopathy and infection at the injection site)
Trial design
Parallel
Treatments tested in this trial
Nylon (Polyamide) Epidural Catheter
DeviceNylon (Polyamide) Epidural Catheter
Polyurethane Epidural Catheter
DevicePolyurethane Epidural Catheter
Treatment groups
Trial outcomes
Primary outcomes
Mean and Standard deviation of Time required for epidural catheter insertion (seconds) (mean±SD)
Time interval from holding the epidural catheter by the anesthetist till removal of the Tuohy needle through the epidural catheter by the anesthetist
Secondary outcomes
Mean and Standard deviation of Time required for epidural catheter to anchor with the catheter connector (seconds) (mean±SD)
Time interval from holding the epidural catheter by the anesthetist till anchoring it with the catheter connector by the anesthetist
Mean and Standard deviation of Time required for epidural catheter removal (seconds) (mean±SD)
Time interval from holding the epidural catheter by the anesthetist till removal of the epidural catheter by the anesthetist
Number of participants and Rate of Catheter-related complications
Number of participants and Rate of: Catheter kink, Catheter stretch, Difficult catheter insertion, Intravascular placement, Intrathecal placement, Paresthesia, Failure (asymmetric, unilateral, no block at 30 min), Hematoma, Breakage during removal.
Sponsors and contacts
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