Epidural; AnesthesiaNCT05168943
Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery
A study testing Nylon (Polyamide) Epidural Catheter and Polyurethane Epidural Catheter in people with Epidural; Anesthesia and Catheter Complications, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Epidural; Anesthesia, Catheter Complications, Catheter Blockage
- What is being tested?
- Nylon (Polyamide) Epidural Catheter and Polyurethane Epidural Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Damanhour Teaching Hospital
Damanhūr, El-Beheira
Ahmed M Shaat, MD, 00201223482709, ahmedshaat99@gmail.com
About this study
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.
- Conditions
- Epidural; Anesthesia, Catheter Complications, Catheter Blockage, Catheter Dysfunction, Catheter Breakage
- Being tested
- Nylon (Polyamide) Epidural Catheter, Polyurethane Epidural Catheter
- Keywords
- Epidural Anesthesia, Nylon (Polyamide) Epidural Catheter, Polyurethane Epidural Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nylon (Polyamide) Epidural CatheterDevice
Nylon (Polyamide) Epidural Catheter
Polyurethane Epidural CatheterDevice
Polyurethane Epidural Catheter
| Study group | Role | What they receive |
|---|---|---|
| Group N (n=30) | Active comparator | Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter Receives: Device: Nylon (Polyamide) Epidural Catheter |
| Group P (n=30) | Active comparator | Continuous Epidural Anesthesia using Polyurethane Epidural Catheter Receives: Device: Polyurethane Epidural Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 minutes after identifying the epidural space by loss of resistance technique
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: 2 minutes after the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Jul 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural; AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168943
- Sponsor's protocol ID
- DTH: 21003
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT05168943
- Acronym / sponsor ID
- DTH: 21003
- Conditions
- Epidural; Anesthesia, Catheter Complications, Catheter Blockage, Catheter Dysfunction, Catheter Breakage
- Keywords
- Epidural Anesthesia, Nylon (Polyamide) Epidural Catheter, Polyurethane Epidural Catheter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group N (n=30) | Active comparator | Device: Nylon (Polyamide) Epidural CatheterContinuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter |
| Group P (n=30) | Active comparator | Device: Polyurethane Epidural CatheterContinuous Epidural Anesthesia using Polyurethane Epidural Catheter |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 21 to 60 years
- Body Mass Index (BMI) < 35
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nylon (Polyamide) Epidural CatheterNylon (Polyamide) Epidural Catheter | Device | Group N (n=30) |
| Polyurethane Epidural CatheterPolyurethane Epidural Catheter | Device | Group P (n=30) |
Primary outcome
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
Time interval from holding the epidural catheter by the anesthetist till removal of the Tuohy needle through the epidural catheter by the anesthetist
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed M Shaat, MD principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nylon (Polyamide) Epidural Catheter and Polyurethane Epidural Catheter in people with Epidural; Anesthesia and Catheter Complications, run by Damanhour Teaching Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Shaat, MD (00201223482709, ahmedshaat99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.