Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Damanhour Teaching Hospital

Status: Enrolling

Conditions: Catheter Breakage; Catheter Complications; Catheter Dysfunction; Epidural; Anesthesia; Catheter Blockage

Treatments: Device: Nylon (Polyamide) Epidural Catheter; Device: Polyurethane Epidural Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05168943

DTH: 21003

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group N (n=30)

Active Comparator group

Description:

Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter

Treatment:

Device: Nylon (Polyamide) Epidural Catheter

Group P (n=30)

Active Comparator group

Description:

Continuous Epidural Anesthesia using Polyurethane Epidural Catheter

Treatment:

Device: Polyurethane Epidural Catheter