Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396903
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2006-11-07
Brief Title:
Evaluation of a Standard Epidural Catheter During Clinical Practice
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Evaluation of a Standard Epidural Catheter During Clinical Practice
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 02 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
Reported incidences for paraesthesia vary widely between about 02 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 eg 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 rightleft
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 paraesthesiadifficulties 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
Dosekind 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 complicationsside effects related to epidural anaesthesiaanalgesia ie dural puncture haematoma etc
Judgement of the anaesthesiologist concerning handling features 0 no resistance 1 minor difficulties 2 serious difficulties
Catheter damages
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 eg 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 rightleft
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 paraesthesiadifficulties 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
Dosekind 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 complicationsside effects related to epidural anaesthesiaanalgesia ie dural puncture haematoma etc
Judgement of the anaesthesiologist concerning handling features 0 no resistance 1 minor difficulties 2 serious difficulties
Catheter damages
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None