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NCT Number: NCT05168943

Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

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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Key information

Conditions

Epidural; Anesthesia Catheter Blockage Catheter Breakage Catheter Complications Catheter Dysfunction

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location status: Recruiting

Location contact

Ahmed M Shaat, MD

CONTACT

[email protected]

00201223482709

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nylon (Polyamide) Epidural Catheter

Device

Nylon (Polyamide) Epidural Catheter

Polyurethane Epidural Catheter

Device

Polyurethane Epidural Catheter

Primary outcomes

  1. Mean and Standard deviation of Time required for epidural catheter insertion (seconds) (mean±SD)

    Time frame: 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 outcomes

  1. Mean and Standard deviation of Time required for epidural catheter to anchor with the catheter connector (seconds) (mean±SD)

    Time frame: 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

  2. Mean and Standard deviation of Time required for epidural catheter removal (seconds) (mean±SD)

    Time frame: 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

  3. Number of participants and Rate of Catheter-related complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M Shaat, MD

CONTACT

[email protected]

00201223482709

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2021
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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