E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of post-operative pain after total knee athroplasty |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 17.0 |
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 |
Evaluate the effect of adductor canal block vs. placebo on quadriceps mucle strength assesed by maximum voluntary isometric contraction (MVIC) as procentage of the postoperative preblock baseline, one hour post block. |
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E.2.2 | Secondary objectives of the trial |
Difference in time (seconds) to complete the timed-up-and-go (TUG) test one and two hours post block, between groups.
Difference between the groups, in pain at rest (VAS 0-100 mm) at one and two hours post block.
Difference between the groups, in pain during 45 degreees flexion of the knee (VAS 0-100 mm) at one and two hours post block.
Difference between the groups, in worst pain experienced during the TUG test (VAS 0-100 mm) at one and two hours post block.
Finally, we plan to perfrom a subgroup analysis of muscle strength and time to perfrom the TUG test, by dividing the patients in two groups according to initial pain ( pre block) scores during 45 degrees active knee flexion. Group 1: 0-59 mm VAS score, and group 2: 60-100 mm VAS.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age between 18-85 years.
ASA 1-3.
Total knee replacement during the last 48 hours. |
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E.4 | Principal exclusion criteria |
Allergy to to study drug.
Unable to preform TUG test preoperative.
Patients who have recieved a peripheral or central nerve block post operatively.
Peripheral neuropathy.
Pregnancy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Effect of adductor canal block vs. placebo on quadriceps mucle strength assesed by maximum voluntary isometric contraction (MVIC) as procentage of the postoperative preblock baseline. |
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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 time (seconds) to complete the timed-up-and-go (TUG) test between groups.
Difference between the groups, in pain at rest (VAS 0-100 mm).
Difference between the groups, in pain during 45 degreees flexion of the knee (VAS 0-100 mm).
Difference between the groups, in worst pain experienced during the TUG test (VAS 0-100 mm).
Finally, we plan to perfrom a subgroup analysis of muscle strength and time to perfrom the TUG test, by dividing the patients in two groups according to initial pain ( pre block) scores during 45 degrees active knee flexion. Group 1: 0-59 mm VAS score, and group 2: 60-100 mm VAS.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
One and two 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 | 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) | 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 | Yes |
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 | Yes |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |