NCT05168943 Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery
| NCT ID | NCT05168943 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Damanhour Teaching Hospital |
| Condition | Epidural; Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ahmed M Shaat, MD
PRINCIPAL INVESTIGATOR
Damanhour Teaching Hospital
Frequently Asked Questions
Who can join the NCT05168943 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 60 Years, studying Epidural; Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05168943 currently recruiting?
Yes, NCT05168943 is actively recruiting participants. Contact the research team at ahmedshaat99@gmail.com for enrollment information.
Where is the NCT05168943 trial being conducted?
This trial is being conducted at Damanhūr, Egypt.
Who is sponsoring the NCT05168943 clinical trial?
NCT05168943 is sponsored by Damanhour Teaching Hospital. The principal investigator is Ahmed M Shaat, MD at Damanhour Teaching Hospital. The trial plans to enroll 60 participants.