Safety of Two Epidural Catheters in Thoracic Epidural Anaesthesia (TEA)
Primary Purpose
Anesthesia, Epidural, Paraesthesia
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Perifix Epidural Anaesthesia Catheter
Perifix Standard
Perifix New
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia, Epidural focused on measuring Anaesthetic techniques, epidural, catheters, paraesthesia, side effects, Anesthesia, Epidural [E03.155.086.131]
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for thoracic epidural anaesthesia (TEA), with or without general anaesthesia.
- American Society of Anesthesiologists (ASA) class I-III
- Patients aged 18 and ≤ 75 years of age
Exclusion Criteria:
- Anamnestic exclusion criteria are all contraindications for epidural anaesthesia.
- Severe scoliosis, previous surgery on the spine, M. Bechterew disease
- Non-competent and non-cooperative patients
- Patients with medicament and drug abuse problems, problems in communication, participating in parallel in another clinical study with experimental drugs or devices, receiving prohibited concomitant therapies
Sites / Locations
- University Hospital Maastricht
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
Perifix Standard
Perifix New
Outcomes
Primary Outcome Measures
The primary end-point will be the incidence of spontaneous paraesthesia during catheter insertion in TEA-patients.
Secondary Outcome Measures
The frequency of inadvertent vascular cannulation
Difficulties involved in insertion and removal of the catheter
Data on additional complications
Data for the evaluation of handling characteristics
Full Information
NCT ID
NCT00394459
First Posted
October 31, 2006
Last Updated
May 12, 2011
Sponsor
Maastricht University Medical Center
Collaborators
B. Braun Melsungen AG
1. Study Identification
Unique Protocol Identification Number
NCT00394459
Brief Title
Safety of Two Epidural Catheters in Thoracic Epidural Anaesthesia (TEA)
Official Title
Randomised, Prospective, Single-blind, Controlled Multicenter Study on the Safety of Two Epidural Catheters in Patients Undergoing Surgery Under Thoracic Epidural Anaesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
Collaborators
B. Braun Melsungen AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective: The primary objective is to demonstrate that the safety of Perifix New is non-inferior to using Perifix Standard when applied for thoracic epidural anaesthesia.
Primary Endpoint: Incidence of spontaneous paraesthesia during catheter insertion
Secondary Objectives: The secondary objectives are to determine the safety and performance of the investigational product: frequency of inadvertent vascular cannulation, difficulties involved in insertion and removal of the catheter, other safety features and data for the evaluation of handling characteristics.
Title: Randomised, prospective, single-blind, controlled, study on the safety of two epidural catheters in patients undergoing surgery under thoracic epidural anaesthesia
Investigational Product: Perifix Epidural Anaesthesia Catheter
Test Product: Perifix New
Reference Product: Perifix Standard
Number of Sites and Countries: 1 site in The Netherlands
Indication: Thoracic epidural anaesthesia
Study Design: Randomised, prospective, single-blind, controlled study in 1 study center, phase IV
Perifix New and Perifix Standard meet all the appropriate provisions of the relevant legislation implementing European Directives (both have CE-marking).
Study Duration: 2 year duration
Study Start: March-April 2005
Sample Size: n = 2*70 patients
Detailed Description
Epidural anaesthesia is a central neuraxial block technique with many applications. Improvements in equipment, drugs and technique have made it a popular and versatile anaesthetic technique, with applications in surgery, obstetrics and pain control. Both single injection and catheter techniques can be used. Its versatility means it can be used as an anaesthetic, as an analgesic adjuvant to general anaesthesia, and for postoperative analgesia in procedures involving the lower limbs, perineum, pelvis, abdomen and thorax.
Although epidural anaesthesia is a safe technique, during the insertion of epidural catheters several side effects may occur, including transient paraesthesia and inadvertent vascular cannulation.
Reported incidences for paraesthesia vary widely between about 0.2% and 50% in different articles, depending on the catheter (catheter material, soft-tipped or firm-tipped catheter), the applied technique (lumbar or thoracic epidural anaesthesia, depth of catheter insertion), the approach (midline or paramedian) and the included patients (obstetrical or non-obstetrical). Paraesthesias are not supposed to lead to permanent neurological sequelae, but are unpleasant and perturbing sensations for the patient.
Besides inadvertent intrathecal location of the catheter, further problems include technical difficulties during threading or removal of the catheter. Here, the catheter shaft material seems to be the crucial factor for the incidence of problems.
Based upon years of experience, a wide range of epidural catheters were created, among them the Perifix catheter of B. Braun. Common features are their high tensile strength and stretch resistance, excellent shaft stability with easy visualisation of blood or spinal fluid due to the crystal clear material, no risk of forming loops or knots, and softening of catheter within a few hours due to water absorption of the polyamide material.
Recently, B. Braun Melsungen AG has developed a new generation of Perifix epidural catheters, which are already CE-labeled. These new catheters are different in their composition compared to the current Perifix Standard catheter with regard to the catheter material and tip configuration. They have an outer poly-urethane liner and an inner polyamide body. Experimental tests have shown that the positive features (e.g. pushability, kink resistance, gliding, withdrawal) of the Perifix Standard catheter can be maintained. Due to the polyurethane outer layer, the catheter gets softer when reaching body temperature immediately upon insertion. Based on this, it is expected that paraesthesias during catheter injection can be reduced by at least 20%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Epidural, Paraesthesia
Keywords
Anaesthetic techniques, epidural, catheters, paraesthesia, side effects, Anesthesia, Epidural [E03.155.086.131]
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Perifix Standard
Arm Title
B
Arm Type
Experimental
Arm Description
Perifix New
Intervention Type
Device
Intervention Name(s)
Perifix Epidural Anaesthesia Catheter
Intervention Description
Epidural Catheter
Intervention Type
Device
Intervention Name(s)
Perifix Standard
Intervention Description
Perifix Standard
Intervention Type
Device
Intervention Name(s)
Perifix New
Intervention Description
Perifix New
Primary Outcome Measure Information:
Title
The primary end-point will be the incidence of spontaneous paraesthesia during catheter insertion in TEA-patients.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
The frequency of inadvertent vascular cannulation
Time Frame
1 hour
Title
Difficulties involved in insertion and removal of the catheter
Time Frame
1 week
Title
Data on additional complications
Time Frame
1 week
Title
Data for the evaluation of handling characteristics
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for thoracic epidural anaesthesia (TEA), with or without general anaesthesia.
American Society of Anesthesiologists (ASA) class I-III
Patients aged 18 and ≤ 75 years of age
Exclusion Criteria:
Anamnestic exclusion criteria are all contraindications for epidural anaesthesia.
Severe scoliosis, previous surgery on the spine, M. Bechterew disease
Non-competent and non-cooperative patients
Patients with medicament and drug abuse problems, problems in communication, participating in parallel in another clinical study with experimental drugs or devices, receiving prohibited concomitant therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Gielen, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marco Marcus, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
12. IPD Sharing Statement
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Safety of Two Epidural Catheters in Thoracic Epidural Anaesthesia (TEA)
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