Comparing nylon and polyurethane epidural catheters for orthopedic surgery
Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery
NA · Damanhour Teaching Hospital · NCT05168943
This study is testing whether nylon or polyurethane epidural catheters work better and have fewer problems for patients having major orthopedic surgery with continuous pain relief.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Damanhour Teaching Hospital (other gov) |
| Locations | 1 site (Damanhūr, El-Beheira) |
| Trial ID | NCT05168943 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety and efficacy of nylon (polyamide) epidural catheters versus polyurethane epidural catheters in patients undergoing major orthopedic surgery with continuous epidural anesthesia. It is a prospective, randomized, double-blind study involving 60 patients who will be randomly assigned to receive either type of catheter. The study will assess complications associated with catheter use, such as blockage, dysfunction, and breakage, to determine which material provides better outcomes for patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 60 years with an ASA physical status of II or lower and a BMI under 35.
Not a fit: Patients who are over 60 years old, have a BMI of 35 or higher, or have contraindications to regional anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and effectiveness of epidural anesthesia in orthopedic surgeries.
How similar studies have performed: While this study addresses a common issue in anesthesia, similar studies have not been widely reported, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Damanhūr, El-Beheira
- Damanhour Teaching Hospital — Damanhūr, El-Beheira, Egypt (RECRUITING)
Study contacts
- Principal investigator: Ahmed M Shaat, MD — Damanhour Teaching Hospital
- Study coordinator: Ahmed M Shaat, MD
- Email: ahmedshaat99@gmail.com
- Phone: 00201223482709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epidural, Anesthesia, Catheter Complications, Catheter Blockage, Catheter Dysfunction, Catheter Breakage, Epidural Anesthesia, Nylon Epidural Catheter