E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The use of intrathecal morphine for post-operative pain relief following major abdominal surgery - the comparison of two doses (10 micrograms/kg and 20 micrograms/kg)
medical condition = post-operative pain |
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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 |
To determine the optimal dose for intrathecal morphine in major abdominal surgery for adults |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of each dose in terms of side effects compared with analgesic effect |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The teaching hospital in Coventry is a tertiary referral centre with 900 beds and serves a population of 500,000. The subjects of the study will be patients undergoing major abdominal surgery related to either the vascular system or gastro-intestinal tract. A total of 100 patients will be recruited into the trial. The age range will be 30 to 80 years with no exclusion related to gender. Bias will be controlled by including all patients of all surgeons involved with this type of surgery. This should ensure that patients are representative of the general population undergoing this type of surgery. Patients will be randomly allocated to one of two groups – 50 will receive 10 micrograms intrathecal morphine per kilogram body weight (to a maximum of 1mg) and 50 will receive 20 micrograms intrathecal morphine per kilogram body weight (to a maximum of 2mg). 100 envelopes (50 with 10 micrograms/kg and 50 with 20 micrograms/kg) will be used and the anaesthetist involved with the patient will select one sealed envelope randomly. The study should take between six and twelve months. Surgeons and anaesthetists involved in the trial will be given an information pack related to the study. |
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E.4 | Principal exclusion criteria |
Patients excluded will be those who do not consent, those with clotting abnormalities, systemic infection, those with localised infection of the skin in the lumbar region and women who are pregnant. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Completion of 100 patients and their data collection |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.1 | Randomised | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Same medication - two different doses |
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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 | 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
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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 | |
E.8.9.1 | In the Member State concerned days | |