Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Last updated: February 4, 2025
Sponsor: Damanhour Teaching Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Catheter Complications

Treatment

Nylon (Polyamide) Epidural Catheter

Polyurethane Epidural Catheter

Clinical Study ID

NCT05168943
DTH: 21003
  • Ages 21-60
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status ≤ II

  • Age from 21 to 60 years

  • Body Mass Index (BMI) < 35

Exclusion

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 atthe injection site)

  • Uncooperative patients

  • Patients with known allergy to local anesthetics or opioids

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Nylon (Polyamide) Epidural Catheter
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
July 30, 2025

Connect with a study center

  • Damanhour Teaching Hospital

    Damanhūr, El-Beheira
    Egypt

    Active - Recruiting

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