Anesthesia, EpiduralPhase 4NCT00394459
Safety of Two Epidural Catheters in Thoracic Epidural Anaesthesia (TEA)
A Phase 4 study testing Perifix Epidural Anaesthesia Catheter, Perifix Standard and Perifix New in people with Anesthesia, Epidural and Paraesthesia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Epidural, Paraesthesia
- What is being tested?
- Perifix Epidural Anaesthesia Catheter, Perifix Standard and Perifix New
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2005to May 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Prospective, Single-blind, Controlled Multicenter Study on the Safety of Two Epidural Catheters in Patients Undergoing Surgery Under Thoracic Epidural Anaesthesia
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
Read more
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
Read the 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%.
- Conditions
- Anesthesia, Epidural, Paraesthesia
- Being tested
- Perifix Epidural Anaesthesia Catheter, Perifix Standard, Perifix New
- Keywords
- Anaesthetic techniques, epidural, catheters, paraesthesia, side effects, Anesthesia, Epidural [E03.155.086.131]
- Medical subject headings
- Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perifix Epidural Anaesthesia CatheterDevice
Epidural Catheter
Perifix StandardDevice
Perifix Standard
Perifix NewDevice
Perifix New
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Perifix Standard Receives: Device: Perifix Epidural Anaesthesia Catheter; Device: Perifix Standard |
| B | Experimental | Perifix New Receives: Device: Perifix Epidural Anaesthesia Catheter; Device: Perifix New |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point will be the incidence of spontaneous paraesthesia during catheter insertion in TEA-patients.
Measured: 1 hour
Secondary outcomes (4)
The frequency of inadvertent vascular cannulation
Measured: 1 hour
Difficulties involved in insertion and removal of the catheter
Measured: 1 week
Data on additional complications
Measured: 1 week
Data for the evaluation of handling characteristics
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startApr 2005
- Primary completionMar 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, EpiduralStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Investigators
- Mathieu Gielen, MD, PhD, Study chair, Radboud University Medical CenterMarco Marcus, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394459
- Sponsor's protocol ID
- MEC 04-1-83
- Other IDs
- H-04-078-04
- Status last verified
- May 2011
- First submitted
- 31 Oct 2006
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Prospective, Single-blind, Controlled Multicenter Study on the Safety of Two Epidural Catheters in Patients Undergoing Surgery Under Thoracic Epidural Anaesthesia
- ClinicalTrials.gov ID
- NCT00394459
- Acronym / sponsor ID
- MEC 04-1-83
- Conditions
- Anesthesia, Epidural, Paraesthesia
- Keywords
- Anaesthetic techniques, epidural, catheters, paraesthesia, side effects, Anesthesia, Epidural [E03.155.086.131]
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Study start
- Apr 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 1 Nov 2006 (estimated)
- 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.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Perifix Epidural Anaesthesia Catheter, Device: Perifix StandardPerifix Standard |
| B | Experimental | Device: Perifix Epidural Anaesthesia Catheter, Device: Perifix NewPerifix New |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Perifix Epidural Anaesthesia CatheterEpidural Catheter | Device | A, B |
| Perifix StandardPerifix Standard | Device | A |
| Perifix NewPerifix New | Device | B |
Primary outcome
The primary end-point will be the incidence of spontaneous paraesthesia during catheter insertion in TEA-patients.
Time frame: 1 hour
4 secondary outcomes
The frequency of inadvertent vascular cannulation
Time frame: 1 hour
Difficulties involved in insertion and removal of the catheter
Time frame: 1 week
Data on additional complications
Time frame: 1 week
Data for the evaluation of handling characteristics
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
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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. This study is not recruiting at the moment.
Mathieu Gielen, MD, PhD study chair
Radboud University Medical Center
Marco Marcus, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perifix Epidural Anaesthesia Catheter, Perifix Standard and Perifix New in people with Anesthesia, Epidural and Paraesthesia, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 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: finished, as of the sponsor's last update on 13 May 2011. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end-point will be the incidence of spontaneous paraesthesia during catheter insertion in TEA-patients. (time frame: 1 hour). 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 13 May 2011.