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.

Study Overview

• Status: Recruiting
• Conditions: Catheter Complications; Catheter Blockage; Catheter Dysfunction; Epidural; Anesthesia; Catheter Breakage
• Intervention / Treatment: Device: Nylon (Polyamide) Epidural Catheter; Device: Polyurethane Epidural Catheter

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Shaat, MD; Phone Number: 00201223482709; Email: ahmedshaat99@gmail.com

Study Locations

• Egypt
  • El-Beheira
    • Damanhūr, El-Beheira, Egypt
      • Recruiting
      • Damanhour Teaching Hospital
      • Contact: Ahmed M Shaat, MD; Phone Number: 00201223482709; Email: ahmedshaat99@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group N (n=30); Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter	Device: Nylon (Polyamide) Epidural Catheter; Nylon (Polyamide) Epidural Catheter
Active Comparator: Group P (n=30); Continuous Epidural Anesthesia using Polyurethane Epidural Catheter	Device: Polyurethane Epidural Catheter; Polyurethane Epidural Catheter

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Damanhour Teaching Hospital
• Investigators: Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Epidural Anesthesia; Nylon (Polyamide) Epidural Catheter; Polyurethane Epidural Catheter
• Other Study ID Numbers: DTH: 21003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No