E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoarthritis of the hip and knee joints |
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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 |
The principal research question is whether infiltration of the surgical wound site with a long acting local anaesthetic (levobupivacaine) will provide a superior quality of postoperative pain relief compared to traditional methods such as intravenous morphine. |
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E.2.2 | Secondary objectives of the trial |
The secondary research objectives are: 1)does local infiltration of the wound with levobupivacaine result in earlier mobilisation after hip and knee arthroplasty and 2)does this contribute to a reduced incidence of nausea and vomiting and 3) an ultimately shorter hospital stay? |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria will be: Age (18-85) Males and females American Association of Anesthesiologists (ASA)class I-III. Patients requiring primary hip/knee arthroplasty |
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E.4 | Principal exclusion criteria |
Exclusion criteria will be: Allergy or previous adverse reactions to morphine/levobupivacaine. Inflammatory polyarthritis of a severity likely to compromise postoperative mobility. Refusal on the participants part to consent to the study. ASA class IV and V. Age < 20 and >85. People with learning needs and communication disability. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Following informed and written consent, 200 patients (ASA grades I-III) presenting for primary hip and knee arthroplasty will be studied. Patients will be randomly allocated to two groups A (n=100) and B (n=100). All patients will receive a standardised anaesthetic protocol comprising intrathecal isobaric bupivacaine 0.5% (0.1-0.2 mg/kg), intravenous propofol or midazolam to allow sedation to an appropriate depth, granisetron (1mg) and supplemental oxygen (4 l/min). After surgery all patients will be prescribed a patient controlled analgesia system. (Morphine [1mg/ml], bolus of 1 mg and a lockout time of 5 minutes). Patients in group A will act as controls and will receive no local infiltration of levobupivacaine. Patients in group B will receive local infiltration to the operative site (before wound closure)of levobupivacaine with adrenaline in 100 ml of saline giving a final concentration of 0.2% levobupivacaine in 1:200,000 adrenaline per ml. The morphine consumption in milligrams, pain scores (by a visual analogue scale [VAS]) and the mobility scores for each patient will be assessed in the postoperative period.Postoperative mobilisation will follow a set protocol supervised by a core team of experienced orthopaedic physiotherapists who will be blinded to the type of pain used (Group A or B). The mobility tests performed will comprise; 1)the level of assistance required for transfer from the supine to the sitting position and from the sitting position to the standing position and for mobilisation with a walking aid, 2)a timed 10 metre walk to assess walking velocity, and 3)a timed stair-climbing test. Data collection will commence on an hourly basis immediately after surgery and will continue for 48 hours at which time the study period will end. |
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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 | Information not present in EudraCT |
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 | 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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |