Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorDamanhour Teaching Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) physical status ≤ II

Age from 21 to 60 years

Body Mass Index (BMI) < 35

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nylon (Polyamide) Epidural Catheter

    Device

    Nylon (Polyamide) Epidural Catheter

  • Polyurethane Epidural Catheter

    Device

    Polyurethane Epidural Catheter

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group N (n=30)Active comparator 1 intervention
Group B: Group P (n=30)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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