E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteers (treatment intended for postoperative pain treatment in patients after knee surgery) |
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E.1.1.1 | Medical condition in easily understood language |
healthy volunteers (treatment intended for postoperative pain treatment in patients after knee surgery) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
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 whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block |
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E.2.2 | Secondary objectives of the trial |
To investigate wheteher reducing the volume ropivacaine injected for adductor canal block has any effect on ambulation and reduces sensory effect of the block |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18-30 years
Men
ASA 1
Body Mass Index 18-25 |
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E.4 | Principal exclusion criteria |
Allergy to study medication
Earlier trauma or surgery to the lower limb
Diabetes Mellitus |
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E.5 End points |
E.5.1 | Primary end point(s) |
The difference between the two volumes in number of subjects excperiencing a reduction in quadriceps muscle strength by more than 25% from baseline in two consecutive assessments.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From 30 minutes to 6 hours post block |
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E.5.2 | Secondary end point(s) |
A: The difference between the two volumes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle, assessed as percentage of the baseline value.
B: The difference between the two volumes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle calculated as ”area under the curve” (AUC)
C: The difference between the pre block value and the post block value in the modified 30-second Chair Stand test on one leg, between the two volumes.
D: The difference between the two volumes in VAS pain score during warmth stimulation |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
A: 2, 3 and 4 hours post block
B: Area under the curve for the interval 30 minutes to 6 hours post block
C: Difference from pre block value at 2 and 4 hours post block
D: Mean value for the periode 30 minutes - 6 hours post block |
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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 | No |
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) | 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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 |
different volume of the same product |
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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 |