NCT05168943

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

December 10, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
3.5 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 12, 2026

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

December 10, 2021

Last Update Submit

January 9, 2026

Conditions

Epidural; AnesthesiaCatheter ComplicationsCatheter BlockageCatheter DysfunctionCatheter Breakage

Keywords

Epidural AnesthesiaNylon (Polyamide) Epidural CatheterPolyurethane Epidural Catheter

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    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)

    2 minutes after the end of the operation

  • Number of participants and Rate of Catheter-related complications

    2 minutes after the end of the operation

Study Arms (2)

Group N (n=30)

ACTIVE COMPARATOR

Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter

Device: Nylon (Polyamide) Epidural Catheter

Group P (n=30)

ACTIVE COMPARATOR

Continuous Epidural Anesthesia using Polyurethane Epidural Catheter

Device: Polyurethane Epidural Catheter

Interventions

Nylon (Polyamide) Epidural CatheterDEVICE

Nylon (Polyamide) Epidural Catheter

Group N (n=30)
Polyurethane Epidural CatheterDEVICE

Polyurethane Epidural Catheter

Group P (n=30)

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

RECRUITING

Study Officials

  • Ahmed M Shaat, MD

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Shaat, MD

CONTACT

00201223482709ahmedshaat99@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 23, 2021

Study Start

July 1, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 12, 2026

Record last verified: 2025-06

Locations

EG(1)