E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
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 |
To show the decrease of the postoperative morphine consumption by 30% in the treatment arm (N20/O2) vs treatment arm (N2/O2 and eventual additional sevofluran to obtain a BIS between 40 and 50) during 24 hours (primary outcome) and 72 hours (secondary outcome). |
|
E.2.2 | Secondary objectives of the trial |
- To demonstrate the reduction of the area of hyperalgesia to pin prick (by the Von Frey rigid filaments) around the surgical incision at 24, 48 and 72 hours in the treatment arm (N20/O2) vs control arm (N2/O2) - To emphasis the pain relief at movement (i.e. deep inspiration) at 24, 48 and 72 hours, using the VAS, in the treatment arm (N20/O2) vs treatment arm (N2/O2) - To demonstrate the prolongation of time to first morphine treatment in the treatment arm (N20/O2) - To compare the spontaneous pain assessment immediately before the start of morphine treatment (Verbal rating scale) - To compare the number of adverse events during the post operative period (72 hours) in the different groups -To evaluate the quality of life during a period of 12 months after treatment in both groups. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- types of surgery interventions: major abdominal surgeries with laparotomy of expected length of 4 hours or even specified - adults: 18 to 65 years old - ASA 1-3 - signed patient consent form |
|
E.4 | Principal exclusion criteria |
- Thoracic surgery - Psychotropic agent chronic usage - Chronic pain or chronic use of opioid analgesic - Preceding major abdominal surgery - Expected prolonged intubation - Radiation in the area of surgery - Regular intake of analgesics (except low dose acetylic acid for cardiovascular reasons) - Opioid intake 24 hours before surgery - Major obesity (BMI > 30) - Drug or alcohol abuse - Incapability of handling of PCA - Instable or significant central nervous system, cardiac, hepatic, renal or endocrine dysfunction and/or significant sequelas - Product-related exclusion criteria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Consumption of morphine during 72 hours |
|
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 | No |
E.6.4 | Safety | Yes |
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 | Information not present in EudraCT |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
control treatment: N2/O2 gas mixture |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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
|
last visit of the last patient |
|
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 | 48 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 48 |