Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Sponsor
Damanhour Teaching Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05168943
Collaborator
(none)
60
1
2
6.5
9.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Nylon (Polyamide) Epidural Catheter
  • Device: Polyurethane Epidural Catheter
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery
Actual Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

  1. 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]

    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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damanhour Teaching Hospital Damanhūr El-Beheira Egypt

Sponsors and Collaborators

  • Damanhour Teaching Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Damanhour Teaching Hospital
ClinicalTrials.gov Identifier:
NCT05168943
Other Study ID Numbers:
  • DTH: 21003
First Posted:
Dec 23, 2021
Last Update Posted:
Apr 18, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Damanhour Teaching Hospital

Study Results

No Results Posted as of Apr 18, 2022