RecruitingNot ApplicableNCT05168943

Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery


Sponsor

Damanhour Teaching Hospital

Enrollment

60 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 60 Years

Inclusion Criteria3

  • American Society of Anesthesiologists (ASA) physical status ≤ II
  • Age from 21 to 60 years
  • Body Mass Index (BMI) < 35

Exclusion Criteria6

  • 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

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Interventions

DEVICENylon (Polyamide) Epidural Catheter

Nylon (Polyamide) Epidural Catheter

DEVICEPolyurethane Epidural Catheter

Polyurethane Epidural Catheter


Locations(1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

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NCT05168943


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