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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group N (n=30) | Active Comparator | Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter |
|
| Group P (n=30) | Active Comparator | Continuous Epidural Anesthesia using Polyurethane Epidural Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nylon (Polyamide) Epidural Catheter | Device | Nylon (Polyamide) Epidural Catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 minutes after identifying the epidural space by loss of resistance technique |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 minutes after removal of the Tuohy needle through the epidural catheter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M Shaat, MD | Contact | 00201223482709 | ahmedshaat99@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Shaat, MD | Damanhour Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhour Teaching Hospital | Recruiting | Damanhūr | El-Beheira | Egypt |
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| Polyurethane Epidural Catheter |
| Device |
Polyurethane Epidural Catheter |
|
| 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 |
| 2 minutes after the end of the operation |
| 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. | 2 minutes after the end of the operation |