E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Arthrodese of the lumbar rachis by posterior way |
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MedDRA Classification |
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 |
Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving a single bolus of analgesic, one receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours. |
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E.2.2 | Secondary objectives of the trial |
- Compare between 2 groups the consumption of morphine since J0 to J2 - Estimate the rates of the nausea and the postoperative vomits in 2 groups - Compare between 2 groups the delay up to the first rise - Estimate the quality of sleep - Compare the duration of the stay in hospital - Estimate in 2 groups the level pain at 3 months and at 6 months the surgery after.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients benefiting from of arthrodesis scheduled by a rachis lumbar posterior way - Older than 18 years old - Heavier than 50 kg - Patients in the state health scheme - Patients having signed consent
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E.4 | Principal exclusion criteria |
- Surgery linked to an infectious, tumoral or traumatological cause - Patients suffering of chronic pain define as patients consuming stage 3 analgesic since more than 3 months. - Patients receiving isoptine or flécaïne before surgery - Arthrodesis on more than 3 stages - Impossibility of cooperate with the patient - Contra-indication for the maintain or the installation of a catheter diffusing analgesic - Contra-indication of using local analgesic
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary: We compare the pain between 2 groups by means of the EVA (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16, H24, H48.
Secondary: - The consumption of morphine mg (24 H and 48 H after surgery) - The rate of the nausea and the postoperative vomits defined as the number of patients presenting the symptom on the number of patients in the group. - Delay up to the first rise - Delay will be estimated in hours enter the end of the intervention surgery and the first one night - The quality of the sleep estimated every morning with an analogical visual scale from 0 (very bad quality of sleep) to 10 (excellent quality of sleep) - The duration of stay: calculated in days as the delay between the end of the intervention and the capacity at the exit. - Recall of the patients in 3 and 6 months after the surgery to estimate the persistence of residual pains and if they still consume opioid. We shall ask to the patient to clarify the presence or the absence of pain
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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 | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The same drug at the different concentration |
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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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |