E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain relief after surgery for patients who have undergone hip replacement due to osteoarthritis or other hip pathology |
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E.1.1.1 | Medical condition in easily understood language |
Pain relief after surgery for patients who have undergone hip replacement due to osteoarthritis or other hip pathology |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 whether the use of a continuous intra-articular infusion of local anaesthetic might reduce the need for post-operative opiate use in patients undergoing hip replacement. |
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E.2.2 | Secondary objectives of the trial |
1. Whether patients receiving continuous infusion of local anaesthetic mobilise earlier than those in the control group 2. Whether patients receiving continuous infusion of local anaesthetic are more comfortable when they mobilise compared to controls 3. To compare time to discharge in the two groups 4. To compare the rate of side effects and medical complications in the two groups |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Men and women aged 18-99 • ASA 1-3 • Able to give informed consent • Fit to undergo elective primary total hip arthroplasty |
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E.4 | Principal exclusion criteria |
• Any patient already taking opioid analgesia or NSAIDs including aspirin • Allergy/sensitivity to local anaesthetics agents • Allergy/sensitivity to NSAIDs • Allergy/sensitivity to adrenaline • Patients taking anti-coagulant medication • Severe liver disease • Severely impaired renal function • Severe heart failure • Active cerebrovascular bleeding • Severe coagulation disorders • Severe asthma or previous bronchospasm with NSAIDs • Porphyria • Active peptic ulcer disease or acute GI bleed • Any patient unable to consent or understand the pump function • Bilateral hip replacements • Pregnancy/lactation (routine pregnancy tests are carried out pre-operatively on all patients of child bearing age) • Any patient already enrolled in another study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is a 30% reduction in the number of patients requiring opiate analgesia in the 48 hour post-operative period in the treatment group compared to the placebo group. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The opiate requirement and pain scores of patients in both the treatment and control group will be recorded and assessed for the 48h time period following surgery. This is the duration of either treatment or placebo infiltration. |
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E.5.2 | Secondary end point(s) |
1) Pain scores postoperatively as measured using a visual analogue pain score 2) Time to first mobilisation 3) Time to independent mobilisation 4) Time to fulfill discharge criteria 5) Time to hospital discharge 6) Cost effectiveness of using LIA 7) Urinary retention post operatively 8) DVT /PE rate at up to outpatient follow up 9) Side effects and general medical complications 10) Rate of wound/pain pump catheter insertion site infection |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary end points 1-7 and 10 will all be evaluated up to 48 hours post-operatively. End points 8 and 9 will be evaluated up to the final outpatient review which will be at 6-12 weeks post-operatively. |
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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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |