Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

NCT ID: NCT05168943

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epidural; Anesthesia Catheter Complications Catheter Blockage Catheter Dysfunction Catheter Breakage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group N (n=30)

Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter

Group Type ACTIVE_COMPARATOR

Nylon (Polyamide) Epidural Catheter

Intervention Type DEVICE

Nylon (Polyamide) Epidural Catheter

Group P (n=30)

Continuous Epidural Anesthesia using Polyurethane Epidural Catheter

Group Type ACTIVE_COMPARATOR

Polyurethane Epidural Catheter

Intervention Type DEVICE

Polyurethane Epidural Catheter

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nylon (Polyamide) Epidural Catheter

Nylon (Polyamide) Epidural Catheter

Intervention Type DEVICE

Polyurethane Epidural Catheter

Polyurethane Epidural Catheter

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Damanhour Teaching Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed M Shaat, MD

Role: PRINCIPAL_INVESTIGATOR

Damanhour Teaching Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed M Shaat, MD

Role: CONTACT

00201223482709

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahmed M Shaat, MD

Role: primary

00201223482709

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DTH: 21003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.