E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain in patients with hip fracture |
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E.1.1.1 | Medical condition in easily understood language |
Pain in patients with hip fracture |
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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 | 17.1 |
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 is to investigate if the addition of Dexamethasone to Bupivacaine for preoperative analgesia with a femoral nerve block in patients with hip fracture results in prolonged analgesia compared to plain Bupivacaine without Dexamethasone |
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E.2.2 | Secondary objectives of the trial |
Investigat the course of pain reduction until 30 minutes after the nerve block Success rate of sufficient analgesia after femoral nerve block for pain in patients with hip fracture Number of patients without cessation of analgesia at the time of operation If insufficient anesthesia of both divisions of the femoral nerve is correlated to insufficient analgesia of the fractured hip pain |
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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 (0-10trail) ≥ 7 with passive leg raise at the time of inclusion Patients informed consent |
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E.4 | Principal exclusion criteria |
Hip fracture not confirmed by x-ray Weight < 40 kg Verbal pain score > 3, 30 minutes after the nerve block Verbal pain score > 5 with passive leg raise, 30 minutes after the nerve block Patient has previously beeb included in this trial Ongoing pre traumatic treatment with parenteral or intravenous adrenocortical hormone Verbal pain score > 3 from other locations than the fractured hip If the patient wishes to be excluded Allergy to local anesthetics or adrenocortical hormone Visible infection in the area of the point of needle injection Acute inability to comprehend and use verbal pain score |
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency of a minimum of 20 hours of analgesia or analgesia at the time of operation in patients with hip fracture after femoral nerve block with Dexamethason added to Bupivacaine compared to plain Bupivacaine |
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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) |
Frequency of a minimum of 22 hours of analgesia or analgesia at the time of operation in patients with hip fracture after femoral nerve block with Dexamethason added to Bupivacaine compared to plain Bupivacaine. Frequency of a minimum of 24 hours of analgesia or analgesia at the time of operation in patients with hip fracture after femoral nerve block with Dexamethason added to Bupivacaine compared to plain Bupivacaine. Frequency of patients who at the time of operation grade the analgesic treatment since inclusion to have been sufficient. Mean time from nerve block to need of opioid analgesia. Use of opioids by 20, 22 and 24 hours. Mean time from nerve block to verbal pain score ≤3 at rest. Mean time from nerve block to verbal pain score ≤5 with passive leg raise. Frequency af reduced cold sensation in the skin area innervated by the Saphenous nerve when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block. Frequency af reduced cold sensation in the skin area innervated by the Rami Cutanei Anteriores Nervi Femoralis when sufficient analgesia versus insufficient analgesia of the fractured hip is experienced 30 minutes after the femoral nerve block. Success rate of sufficient analgesia after femoral nerve block with Dexamethasone added to Bipivacaine compared to plain Bupivacaine. Frequency of insufficient analgesia and frequency of absent analgesic effect after femoral nerve block with Dexamethasone added to Bipivacaine compared to plain Bupivacaine Frequency of patients with hip fracture without sufficient analgesia after femoral nerve block at 30 minutes Frequency af possible ultrasound visualisation af the femoral nerve
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0 minutes 30 minutes 20 hours 22 hours 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 15 |