Catheter Blockage, Catheter Breakage, Catheter Complications, Catheter Dysfunction, Epidural; Anesthesia
Conditions
Keywords
Epidural Anesthesia, Nylon (Polyamide) Epidural Catheter, Polyurethane Epidural Catheter
Brief summary
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.
Interventions
DEVICENylon (Polyamide) Epidural Catheter
Nylon (Polyamide) Epidural Catheter
DEVICEPolyurethane Epidural Catheter
Polyurethane Epidural Catheter
Sponsors
Damanhour Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status ≤ II * Age from 21 to 60 years * Body Mass Index (BMI) \< 35
Exclusion criteria
* 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) * Uncooperative patients * Patients with known allergy to local anesthetics or opioids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard deviation of Time required for epidural catheter insertion (seconds) (mean±SD) | 2 minutes after identifying the epidural space by loss of resistance technique | Time interval from holding the epidural catheter by the anesthetist till removal of the Tuohy needle through the epidural catheter by the anesthetist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard deviation of Time required for epidural catheter to anchor with the catheter connector (seconds) (mean±SD) | 2 minutes after removal of the Tuohy needle through the epidural catheter | 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) | 2 minutes after the end of the operation | 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 | 2 minutes after the end of the operation | 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. |
Countries
Egypt
Contacts
Primary ContactAhmed M Shaat, MD
Outcome results
None listed