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 | 18.1 |
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 |
The objective of the trail is to investigate if the combination af a femoral and a obturator nerve block provides better analgesia that a femoral nerve block alone, in patients with hip fracture |
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E.2.2 | Secondary objectives of the trial |
Course of analgesic effect Patient satisfaction Feasibility of nerve blocks Time used for nerve blocks Relation between type of fracture and analgesic effect |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Clinical suspicion of hip fracture Age ≥ 55 years Mentally capable of comprehending and using verbal pain score and distinguish between pain from the fractured hip and pain from other location. Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call Verbal pain score (0-10) > 3 at rest or > 5 with dynamic test Patients informed consent |
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E.4 | Principal exclusion criteria |
Hip fracture not confirmed by x-ray Weight < 40 kg Patient has previously been included in this trial If the patient wishes to be excluded Visible infection in the area of the point of needle injection |
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E.5 End points |
E.5.1 | Primary end point(s) |
Succesrate of succesful analgesic effect 30 minutes after nerve blocks compared between the groups |
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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) |
Median NRS 30 minutes after nerve blocks. Course of pain reduction until 30 minutes. Time to succesful analgesic effect. Cutaneous termanalgesia in the area of RCA of the femoral nerve and the saphenous nerve compared to the analgesic effect. Focus af worst pain before nerve blocks and after 30 minutes. Discomfort related to the block procedure Patient satisfaction with analgesia 30 minutes after block. Frequency of possible ultrasonographic visualization of the femoral nerve and area of injection for the obturator nerve block. Time used for femoral nerve block. Time used for obturator nerve block. Total amount of opioid given from the time of nerve blok to operation compared between groups Amount of opioid per time-unit given from the time of nerve block to operation compared between groups. Total amount of opioid given from the time of nerve blok until 10 hours after, compared between groups. Amount of opioid per time-unit given from the time of nerve block until 10 hours after, compared between groups.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0 minutes 30 minutes 10 hours Approx 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 | 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 | 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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |