Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nylon (Polyamide) Epidural Catheter, Polyurethane Epidural Catheter.
- Who it may be relevant to
- Registry conditions: Epidural; Anesthesia, Catheter Complications, Catheter Blockage, Catheter Dysfunction. Basic parameters: 21 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Nylon (Polyamide) Epidural Catheter
Nylon (Polyamide) Epidural Catheter - Device Polyurethane Epidural Catheter
Polyurethane Epidural Catheter
Primary outcome measures
- Mean and Standard deviation of Time required for epidural catheter insertion (seconds) (mean±SD) [Time frame: 2 minutes after identifying the epidural space by loss of resistance technique]
Secondary outcome measures (3)
- Mean and Standard deviation of Time required for epidural catheter to anchor with the catheter connector (seconds) (mean±SD) [Time frame: 2 minutes after removal of the Tuohy needle through the epidural catheter]
- Mean and Standard deviation of Time required for epidural catheter removal (seconds) (mean±SD) [Time frame: 2 minutes after the end of the operation]
- Number of participants and Rate of Catheter-related complications [Time frame: 2 minutes after the end of the operation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Egypt · 1 center
- Damanhour Teaching Hospital — Damanhūr
Identifiers
NCT: NCT05168943 · DTH: 21003