E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (treatment intended for pain treatment in patients after hip surgery) |
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E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers (treatment intended for pain treatment in patients after hip surgery) |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
E.1.2 | System Organ Class | 100000004863 |
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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 |
To investigate the sensory distribution of a LFCN-block with two different doses |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age >18 ASA 1-2 BMI >18 and < 30 Written informed consent |
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E.4 | Principal exclusion criteria |
Allergy to study medication Alcohol abuse (as judged by the investigator) Medical abuse (as judged by investigator) Daily intake of perscription painkillers within the last 4 weeks Intake of over the counter medication within 48 hours Earlier trauma, neuromusclare diseases, or surgery to lower limb (from the hip to the knee) Diabetes mellitus Cant cooperate Cant speak or understand danish Woulds in the investigated area Pregnant women Large tattoos in the area of investigation |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml, assessed by cold sensation with an alcohol swab. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
-Difference in the percentage coverage of the incision (anterolateral approach) between the side givenropivacain, 16 ml, versus the side given ropivacain, 8 ml, assessed by cold sensation with an alcohol swab.
-Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml, assessed by pinprick (von frey).
-Difference in the percentage coverage of the incision (anterolateral approach) between the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml, assessed by pinprick (von frey).
-The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach) on the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml.
-The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach) on the side givenropivacain, 16 ml, versus the side given ropivacain, 8 ml.
-The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterolateral approach) on the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml.
-The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterolateral approach) on the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml.
-Estimation of the areal of the sensory loss (including fotodocumentation) on the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml. Marked with the incicions
-The difference in MVIC (maksimal voluntary isometric contraktion) of the knee joint between the side given ropivacain, 16 ml, versus the side given ropivacain, 8 ml. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
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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 |