E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The management of acute pain after intermediate thoracic surgery
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066714 |
E.1.2 | Term | Acute pain |
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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 |
To determine if oxycodone modified release reduces static and dynamic pain intensity after intermediate thoracic surgery.
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E.2.2 | Secondary objectives of the trial |
Does OxyContin (modified release Oxycodone) 10mg bd reduce intravenous morphine Patient Controlled Analgesia (PCA) consumption in the immediate 48hrs postoperatively?
Does OxyContin 10mg bd reduce the frequency and intensity of opioid related side-effects?
Does OxyContin10mg improve the quality of patients’ recovery and reduce hospital length of stay? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
o Adults over the age of 18 years able to give informed consent o Patients able to write and understand English o Patients scheduled for intermediate thoracic surgery, likely to require intravenous patient controlled analgesia (PCA). This group may include patients scheduled for talc pleurodesis or pleural abrasion.
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E.4 | Principal exclusion criteria |
o Patients having heart, heart-lung and lung transplantation surgery o Patients who have had a previous thoracotomy o Patients scheduled for thoracotomy o Patients with pre-operative opioid use (thus not opioid naive) o Patients with chronic painful syndromes o Inability to understand the concept of PCA o Inability to understand English o Known allergy or sensitivity to opioids o Previous Abdominal Surgery (including oesophageal/gastric) o Patients taking medicines to enhance gastric transit (eg metoclopramide)
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E.5 End points |
E.5.1 | Primary end point(s) |
Parenteral opioid (PCA morphine) consumption in mg at 12, 24, 36 and 48 hours Static pain intensity measured using a visual analogue scale (SVAS) at 4 hour intervals Dynamic pain intensity measured using a visual analogue scale (DVAS) at 4 hours intervals Pain location, nature and PPI measured using the short form McGill Pain Questionnaire (SF-MPQ) Quality of recovery measured using the QOR-40 assessment tool Duration of hospital stay
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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 | 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 | 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 | Yes |
E.8.2.3 | Other | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |