Clinical Trial Results:
Minimal local anaesthetic volumes for sciatic nerve blockade: A clinical evaluation of ED99 volumes
Summary
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EudraCT number |
2012-005075-14 |
Trial protocol |
AT |
Global end of trial date |
09 Sep 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
13 May 2021
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First version publication date |
13 May 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
1.0
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Währinger Gürtel 18-20, Vienn, Austria, 1090
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Public contact |
Daniela Marhofer, Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmed und Schm, +43 1404004100, daniela.marhofer@meduniwien.ac.at
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Scientific contact |
Daniela Marhofer, Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmed und Schm, +43 1404004100, daniela.marhofer@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Oct 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Sep 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Sep 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the study is to investigate if the previously evaluated ED99 for ultrasound guided peripheral nerve blockade is transferable for surgical anaesthesia and analgesia.
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Protection of trial subjects |
+ Full clinical evaluation of the patients before inclusion in study
+ Perioperative continuous monitoring of vital parameters (blood pressure, ECG, oxygen saturation)
+ Ultrasound guided blockade of the sciatic nerve (real-time)
+ One week after the study, all patients were examined for signs of infection or haematoma.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Nov 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
15
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
After ethical approval, all patients were informed about the nature, scope, procedures, and associated risks of the study. The patients were undergoing foot surgery at the Department of Plastic and Reconstructive Surgery (Medical University of Vienna) | ||||||||||
Pre-assignment
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Screening details |
Inclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia. | ||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||
Roles blinded |
Subject, Investigator | ||||||||||
Arms
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Arm title
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Ropivacain | ||||||||||
Arm description |
nclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia. | ||||||||||
Arm type |
Active comparator | ||||||||||
Investigational medicinal product name |
Ropivacain
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Epidural use
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Dosage and administration details |
0,75% extra-epineural Injektion
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Ropivacain
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Inclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body
mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the
study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia.
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End points reporting groups
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Reporting group title |
Ropivacain
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Reporting group description |
nclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia. | ||
Subject analysis set title |
Ropivacain
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Inclusion criteria:surgery in the distribution of the sciatic nerve; age between 18 and 90 years; body
mass index < 35 kg.m!2, no legal incapacity, Exclusion criteria:known allergy or hypersensitivity to the
study drug; abnormal electrocardiogram (ECG), either atrioventricular block or bradycardia.
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End point title |
surgical analgesia [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Sensory and motor block time was defined as the time from performing the block until pinprick < 10% and motor score = 0 (in comparison with the contralateral side)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Sensory and motor block time was defined as the time from performing the block until pinprick < 10% and motor score = 0 (in comparison with the contralateral side) |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From beginning of the study when performing the block for the operation until 1 week after the intervention/operation
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17.1
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Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There was no Adverse events in this Study |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/25644578 |