Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Conditions
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Epidural; Anesthesia, Catheter Complications, Catheter Blockage, Catheter Dysfunction, Catheter Breakage

Intervention / Treatment
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* Device: Nylon (Polyamide) Epidural Catheter
* Device: Polyurethane Epidural Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group N (n=30)<br>Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter | Device: Nylon (Polyamide) Epidural Catheter<br>* Nylon (Polyamide) Epidural Catheter<br>|
| Active Comparator: Group P (n=30)<br>Continuous Epidural Anesthesia using Polyurethane Epidural Catheter | Device: Polyurethane Epidural Catheter<br>* Polyurethane Epidural Catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural Anesthesia, Nylon (Polyamide) Epidural Catheter, Polyurethane Epidural Catheter