E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017284 |
E.1.2 | Term | Fractured femoral neck |
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 |
Validation of a new nerve block technique, the Gluteus Medius Fascia Plane Block(GMFPB) in order to improver the postoperative analgesia in patients with hip fracture. |
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E.2.2 | Secondary objectives of the trial |
Success rates of variations of the nerve block (Supplement of a secondary injection of local anaesthetic in a more superficial layer, GMFPB+ and the secondary injection alone, SI) Description of the anaesthetized skin area after GMFPB, GMFPB+ and SI. Duration of effect of GMFPB, GMFPB+ and SI. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age ≥ 18 years -Mentally capable of cooperating during the trial. -ASA i or II - Written informed consent - Understanding and speaking Danish or English. -No anatomical og technical issues that could make nerve block in the hip region impossible. |
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E.4 | Principal exclusion criteria |
-Allergy to local anaesthetics -Current pregnancy -Weight less than 50 kg -Infection in the area of injection
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E.5 End points |
E.5.1 | Primary end point(s) |
-Success rate of anaesthetizing the skin on the lateral side of the hip in the level of the greater trochanter of the femur all the way distal to the innervated skin area of the lateral femoral cutaneous nerve after GMFPB compared to placebo. |
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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) |
-Success rate of anaesthetizing the skin on the lateral side of the hip in the level of the greater trochanter of the femur all the way distal to the innervated skin area of the lateral femoral cutaneous nerve after GMFPB compared to SI-
-The total, anterior, posterior and cranial area anaesthetized after GMFPB compared to SI
--Success rate of anaesthetizing the skin on the lateral side of the hip in the level of the greater trochanter of the femur all the way distal to the innervated skin area of the lateral femoral cutaneous nerve after GMFPB compared to GMFPB+
--The total, anterior, posterior and cranial area anaesthetized after GMFPB compared to SI
-Mean distance from most cranial part of the skin area anaethetized after Lateral Femoral Cutaneous Nerve(LFCN) block to the greater trochanter of the femur at the level of latter
- Mean distance from the most distal part of the skin areas anaesthetized by GMFPB, GMFPB+ and SI to the most cranial part of the skin area anaethetized after LFCN block at the level of the greater trochanter in the cases where these areas do not overlap.
-Mean distance from the most distal part of the skin areas anaesthetized by GMFPB, GMFPB+ and SI to the greater trochanter of the femur at the level of the greater trochanter in the cases where the skin areas do not overlap with the skin area anesthetized after LFCN block .
- Duration of effect |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 minutes 250 minutes 360 minutes 24 hours |
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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 | 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 | 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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 2 |