E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain after total hip replacement surgery |
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E.1.1.1 | Medical condition in easily understood language |
Pain after total hip replacement surgery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
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 | 10044088 |
E.1.2 | Term | Total hip replacement |
E.1.2 | System Organ Class | 100000004865 |
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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 |
Investigation of the influence of a lateral cutaneus nerve of the thigh block on postoperative pain after total hip replacement surgery with visual analog scale. Total oxynorm dose 1. day after surgery. |
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E.2.2 | Secondary objectives of the trial |
Total oxynorm dose under the complete admission. Time from operation to the first dose of oxynorm. Reduced motoric function under early mobilisation (CAS-score). Time for the first mobilisation. Total admissiontime. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients to primary total hip replacement. |
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E.4 | Principal exclusion criteria |
Patients undergoing general anesthesia
Allergy to local anesthetics of the amide type.
Revision surgery.
Bilateral surgery.
Chronic pain patient
Women in the fertile age |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Visual analog pain scale of the patients under movement (elevetion of the operated leg 30 degree above bed or similar. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. VAS score at time 4 hours after admission of the block.
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E.5.2 | Secondary end point(s) |
1. Total oxynorm administration under the 1. day of admission
2. VAS score
3. Total oxynorm administratin under the whole admission
4 Time from the admission of the block to the first administration of oxynorm
5. Validation of the motor block under the early mobilisation
6. Time for the first mobilisation
6. Total admissiontime to the ward |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. After discharge of the patient
2. Time: 0, 1, 2, 4, 8, 12 and 24 hours after admission of the block
3. After discharge of the patient
4. After discharge of the patient
5. After the first mobilisation of the patient
6. After the first mobilisation of the patient
7. After discharge of the patient |
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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 | No |
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 | 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 | 50 |
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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |