Patients Scheduled for Epidural AnaesthesiaNCT00396903
Evaluation of a Standard Epidural Catheter During Clinical Practice
An observational study of Patients Scheduled for Epidural Anaesthesia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
During the insertion of epidural catheters several complications can occur, including transient paraesthesia and inadvertent venous 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients Scheduled for Epidural Anaesthesia
- What is being tested?
- catheter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2003to Nov 2005
- Phase
- Observational
- 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
- scheduled for Epidural Anaesthesia
- ASA class I-III
- between 18 and 75
Who cannot join
- contraindications for epidural anaesthesia
- Non-competent and non-cooperative
- pregnant and breast-feeding women
- medicament- and drug abuse or problems in communication
- participating in parallel in another clinical study with experimental drugs or devices
Trial locations and contacts
1 site in 1 country.
About this study
During the insertion of epidural catheters several complications can occur, including transient paraesthesia and inadvertent venous 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 anesthesia, depth of catheter insertion), the approach (midline or paramedian) and the included patients (obstetrical or non-obstetrical). Furthermore, the inconsistent definition of "paraesthesia" makes it difficult to compare the results of different studies. Paraesthesia are not supposed to lead to permanent neurological sequelea, but are unpleasant and perturbing sensations for the patient.
Read more
For inadvertent venous cannulation during epidural catheter placement, incidences between 1% and 14% have been reported. As for the paraesthesia rate, catheter material, technique, approach and included patients are determinants for the incidence of vessel puncture.
Main objective of this study is to determine the incidence of paraesthesia with this catheter.
Secondary objectives are to record
- the frequency of inadvertent venous cannulation
- difficulties involved in insertion and removal of the catheter
- data on additional complications
- data for the evaluation of handling characteristics
Read the detailed description
Study design
This study is a prospective, uncontrolled, open, non-randomised study ("Observational Study") with a CE-certified medical device.
Patients
Information and consent Information of the procedure and oral consent of epidural anaesthesia for the surgery is obtained as usual. Oral consent for data collection has to be obtained. No randomisation or blinding is performed and no non-standard procedures are necessary.
Inclusion criteria 100 patients scheduled for Epidural Anaesthesia will be included in this study. Eligible patients are ASA class I-III, between 18 and 75 years of age and are scheduled for EA, with or without general anaesthesia.
Exclusion criteria Anamnestic exclusion criteria are all contraindications for epidural anaesthesia (e.g. neurological deficit, skin infection of the puncture site, diseases leading to neurological impairment such as diabetes, coagulation impairment). Non-competent and non-cooperative patients as well as pregnant and breast-feeding women are also to be excluded. Same applies for patients with medicament- and drug abuse or problems in communication or those participating in parallel in another clinical study with experimental drugs or devices.
Randomisation and Blinding No randomization is required. An independent observer who is not performing the epidural will record occurrence, incidence and intensity of paraesthesia.
Definition of the main and the secondary criteria
Main criteria
- Frequency of paraesthesia during catheter insertion
Secondary criteria
- Frequency of inadvertent venous cannulation (aspiration of blood)
- Intensity of paraesthesia (VAS)
- description: - pain
- electric shock
- burning sensation
- shooting effect
- motor reactions (right/left)
- discomfort
- others
- Frequency and kind of difficulties during insertion of the catheter (rating of "easiness of insertion": 0 = no resistance, 1 = minor difficulties, 2 = serious difficulties, 3 = impossible)
- Facultative: Documentation of paraesthesia/difficulties during catheter removal at 48 hours after surgery (or earlier, if appropriate)
Concomitant parameters
- Patient data (age, height, weight, sex, diagnosis, kind of intervention, ASA class, relevant co-diagnosis, relevant co-medication)
- Epidural anaesthesia and -analgesia related data
- Data that relate to the description of the puncture process and method chosen in case of difficulties during puncture, catheter insertion and removal
- Level of sensory blockade
- Indwelling time of epidural catheter by recording the time of insertion
- Dose/kind of anaesthetic used for epidural anaesthesia, type of general anaesthesia if relevant
- Kind of analgesia done by epidural catheter
- Adequacy of epidural anaesthesia (yes / no)
- Further complications/side effects related to epidural anaesthesia/analgesia (i.e. dural puncture, haematoma, etc)
- Judgement of the anaesthesiologist concerning handling features (0 = no resistance, 1 = minor difficulties, 2 = serious difficulties)
- Catheter damages
- Being tested
- catheter
- Keywords
- Anaesthetic techniques, epidural catheters, paraesthesia, side effects.
- Medical subject headings
- Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of paraesthesia during catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startApr 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Scheduled for Epidural AnaesthesiaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Marcus, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396903
- Sponsor's protocol ID
- O-H-0403
- Status last verified
- Apr 2015
- First submitted
- 7 Nov 2006
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bouman EA, Gramke HF, Wetzel N, Vanderbroeck TH, Bruinsma R, Theunissen M, Kerkkamp HE, Marcus MA. Evaluation of two different epidural catheters in clinical practice. narrowing down the incidence of paresthesia! Acta Anaesthesiol Belg. 2007;58(2):101-5.
PubMed 17710897
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Standard Epidural Catheter During Clinical Practice
- ClinicalTrials.gov ID
- NCT00396903
- Acronym / sponsor ID
- O-H-0403
- Keywords
- Anaesthetic techniques, epidural catheters, paraesthesia, side effects.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Nov 2005 (actual)
- First posted
- 8 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.
During the insertion of epidural catheters several complications can occur, including transient paraesthesia and inadvertent venous 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 anesthesia, depth of catheter insertion), the approach (midline or paramedian) and the included patients (obstetrical or non-obstetrical). Furthermore, the inconsistent definition of "paraesthesia" makes it difficult to compare the results of different studies. Paraesthesia are not supposed to lead to permanent neurological sequelea, but are unpleasant and perturbing sensations for the patient.
For inadvertent venous cannulation during epidural catheter placement, incidences between 1% and 14% have been reported. As for the paraesthesia rate, catheter material, technique, approach and included patients are determinants for the incidence of vessel puncture.
Main objective of this study is to determine the incidence of paraesthesia with this catheter.
Secondary objectives are to record
- the frequency of inadvertent venous cannulation
- difficulties involved in insertion and removal of the catheter
- data on additional complications
- data for the evaluation of handling characteristics
Detailed description
Study design
This study is a prospective, uncontrolled, open, non-randomised study ("Observational Study") with a CE-certified medical device.
Patients
Information and consent Information of the procedure and oral consent of epidural anaesthesia for the surgery is obtained as usual. Oral consent for data collection has to be obtained. No randomisation or blinding is performed and no non-standard procedures are necessary.
Inclusion criteria 100 patients scheduled for Epidural Anaesthesia will be included in this study. Eligible patients are ASA class I-III, between 18 and 75 years of age and are scheduled for EA, with or without general anaesthesia.
Exclusion criteria Anamnestic exclusion criteria are all contraindications for epidural anaesthesia (e.g. neurological deficit, skin infection of the puncture site, diseases leading to neurological impairment such as diabetes, coagulation impairment). Non-competent and non-cooperative patients as well as pregnant and breast-feeding women are also to be excluded. Same applies for patients with medicament- and drug abuse or problems in communication or those participating in parallel in another clinical study with experimental drugs or devices.
Randomisation and Blinding No randomization is required. An independent observer who is not performing the epidural will record occurrence, incidence and intensity of paraesthesia.
Definition of the main and the secondary criteria
Main criteria
- Frequency of paraesthesia during catheter insertion
Secondary criteria
- Frequency of inadvertent venous cannulation (aspiration of blood)
- Intensity of paraesthesia (VAS)
- description: - pain
- electric shock
- burning sensation
- shooting effect
- motor reactions (right/left)
- discomfort
- others
- Frequency and kind of difficulties during insertion of the catheter (rating of "easiness of insertion": 0 = no resistance, 1 = minor difficulties, 2 = serious difficulties, 3 = impossible)
- Facultative: Documentation of paraesthesia/difficulties during catheter removal at 48 hours after surgery (or earlier, if appropriate)
Concomitant parameters
- Patient data (age, height, weight, sex, diagnosis, kind of intervention, ASA class, relevant co-diagnosis, relevant co-medication)
- Epidural anaesthesia and -analgesia related data
- Data that relate to the description of the puncture process and method chosen in case of difficulties during puncture, catheter insertion and removal
- Level of sensory blockade
- Indwelling time of epidural catheter by recording the time of insertion
- Dose/kind of anaesthetic used for epidural anaesthesia, type of general anaesthesia if relevant
- Kind of analgesia done by epidural catheter
- Adequacy of epidural anaesthesia (yes / no)
- Further complications/side effects related to epidural anaesthesia/analgesia (i.e. dural puncture, haematoma, etc)
- Judgement of the anaesthesiologist concerning handling features (0 = no resistance, 1 = minor difficulties, 2 = serious difficulties)
- Catheter damages
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled for Epidural Anaesthesia
- ASA class I-III
- between 18 and 75
Key exclusion criteria (5 listed)
- contraindications for epidural anaesthesia
- Non-competent and non-cooperative
- pregnant and breast-feeding women
- medicament- and drug abuse or problems in communication
- participating in parallel in another clinical study with experimental drugs or devices
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 |
|---|---|---|
| catheter | Device | – |
Primary outcome
Frequency of paraesthesia during catheter insertion
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 8 Apr 2015.
- Results publication: PubMed 17710897Bouman EA, Gramke HF, Wetzel N, Vanderbroeck TH, Bruinsma R, Theunissen M, Kerkkamp HE, Marcus MA. Evaluation of two different epidural catheters in clinical practice. narrowing down the incidence of paresthesia! Acta Anaesthesiol Belg. 2007;58(2):101-5.
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.
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?
An observational study of Patients Scheduled for Epidural Anaesthesia, 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 5 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 8 Apr 2015. 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.
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?
Frequency of paraesthesia during catheter insertion. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396903, which also lists 1 linked publication.
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 8 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.