Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Catheter Complications Clinical Trial

Official title:

Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05168943
• Other study ID #: DTH: 21003
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2023
• Source: Damanhour Teaching Hospital
• Contact: Ahmed M Shaat, MD
• Phone: 00201223482709
• Email: ahmedshaat99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Blockage
• Catheter Complications
• Catheter Dysfunction
• Epidural; Anesthesia

Intervention

Device:
• Nylon (Polyamide) Epidural Catheter
Nylon (Polyamide) Epidural Catheter
• Polyurethane Epidural Catheter
Polyurethane Epidural Catheter

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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