An interventional study of Nylon (Polyamide) Epidural Catheter and Polyurethane Epidural Catheter in Epidural; Anesthesia, Catheter Complications and Catheter Blockage, sponsored by Damanhour Teaching Hospital. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Damanhour Teaching Hospital · Not applicable, Interventional, and Other
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.
Damanhour Teaching Hospital is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter
Device: Nylon (Polyamide) Epidural Catheter
Continuous Epidural Anesthesia using Polyurethane Epidural Catheter
Device: Polyurethane Epidural Catheter
Nylon (Polyamide) Epidural Catheter
Polyurethane Epidural Catheter
Mean and Standard deviation of Time required for epidural catheter insertion (seconds) (mean±SD)
Time interval from holding the epidural catheter by the anesthetist till removal of the Tuohy needle through the epidural catheter by the anesthetist
Time frame: 2 minutes after identifying the epidural space by loss of resistance technique
Mean and Standard deviation of Time required for epidural catheter to anchor with the catheter connector (seconds) (mean±SD)
Time interval from holding the epidural catheter by the anesthetist till anchoring it with the catheter connector by the anesthetist
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 interval from holding the epidural catheter by the anesthetist till removal of the epidural catheter by the anesthetist
Time frame: 2 minutes after the end of the operation
Number of participants and Rate of Catheter-related complications
Number of participants and Rate of: Catheter kink, Catheter stretch, Difficult catheter insertion, Intravascular placement, Intrathecal placement, Paresthesia, Failure (asymmetric, unilateral, no block at 30 min), Hematoma, Breakage during removal.
Time frame: 2 minutes after the end of the operation
Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.
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Damanhour Teaching Hospital