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Recruiting NCT05168943

Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

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

Sex: All
Ages: 21 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Damanhour Teaching Hospital

Location: Damanhour Teaching Hospital Damanhūr El-Beheira

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05168943). StuddyBuddy aggregates publicly available trial information.