E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Proximal traumatic fractured neck of femur |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029173 |
E.1.2 | Term | Nerve block |
|
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 |
Can we reduce the dose of local anaesthetic required to provide pain relief to patients with a broken hip by determining the dose based on the amount of the drug required to relieve pain? |
|
E.2.2 | Secondary objectives of the trial |
What are the blood levels of local anaesthetic associated with the dose of local anaesthetic calculated to be effective in 95 out of 100 patients with a fractured neck of femur. How long does it take for the pain scores to half from the original value with the dose that is effective in 95 out of 100 patients? |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Emergency proximal fractured neck of femur Visual analogue pain score at rest of >=50/100 American Society of Anaesthesiology grading <=4 Able to give informed consent Resting visual analogue pain score of greater than 50mm on a 100mm scale before recruitment to trial Patient is able to cooperate with sensory testing of lower limb function
|
|
E.4 | Principal exclusion criteria |
Abnormal clotting screen (coagulopathy) or thrombocytopenia (<100,000) Confused post or pre operatively (AMT <=7) Allergy to local anaesthetic Contra-indication to levobupivacaine Signs, symptoms or laboratory evidence of local infection or systemic sepsis Pre−existing neurological deficit(sensory or motor) affecting the lower limb Patients who are treated with regional anaesthesia or analgesia procedures not stated in protocol Patients with lower limb amputations or other condition affecting sensation in lower limbs Patient with a history of chronic pain
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Part A: EC50 concentration for levobupivacaine anterior psoas compartment blocks in patient with a fractured neck of femur.
Part B: The duration of analgesia for the EC95% concentration of levobupivacaine(calculated form part A). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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
|
The trial will be terminated when the last patient is recruited and treated in the study |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | 6 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 6 |