E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients scheduled for forefoot surgery are performed an ultrasound guided block. We will evaluate the clinical application of previously evaluated experimental data regarding volume reduction of LA´s for peripheral nerve blockade. Aim is to prove if the little amount of volume which was tested in a volunteers´study effects sufficient conditions for surgical anaesthesia and analgesia. |
|
E.1.1.1 | Medical condition in easily understood language |
Patients undergo an operation in the fore foot receive a nerve block. Aim is to show that the little amount of local anesthetic we tried before in volunteers provides analgesia for an operation. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | 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. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Does 3D ultrasound investigation enables an exact analysis of the distribution of local anesthetic |
|
E.3 | Principal inclusion criteria |
• Patients undergoing plastic-reconstructive surgery in the supply area of the sciatic nerve •Age between 18 and 90 years. •BMI <35 kg.m-2 •Written informed consent given by patients after being provided with detailed information about name, risks and scope of the clinical study as well as the expected desirable and adverse effects of the study drug •No legal incapacity and/or the other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
|
|
E.4 | Principal exclusion criteria |
•Known allergy or hypersensitivity against study drug or drug class •Participation in another clinical study •Abnormalities in ECG that are considered clinically relevant such AV-block or bradycardia •Unreliability or lack of cooperation •Other objections to participate in the study in the opinion of the investigator
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Achievement of anaesthesia and analgesia for surgical conditions |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Pinbrick and motor block tests prior to block and 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 minutes after the block - 30minutes postoperative until full recovery
|
|
E.5.2 | Secondary end point(s) |
Onset of sensory and motor blockade, duration of sensory and motor blockade |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Pinbrick and motor block tests prior to block and 2, 4, 6, 8, 10, 15, 20, 30 and 60 minutes after the block - 30minutes postoperative until full recovery
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
A block with a volume of local anesthetic dependent of the volume the patient received before |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
It is defined in protocol: we complete all planned patients and then the study is finished. If a severe adverse event appear we stop the study.
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |