E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hip and knee osteoarthritis |
|
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 if an injection of local anaesthetic directly into the operation site during total hip or total knee replacement, in addition to the standard anaesthetic regimen, can significantly reduce self-reported joint pain at 1-year after surgery compared to standard anaesthetic alone. |
|
E.2.2 | Secondary objectives of the trial |
To determine, through the pilot study, whether the administration of resource use diaries aids participants in their completion of questionnaires. To explore the acceptability and feasibility of participation in the trial and the intervention through qualitative interviews with patients and healthcare professionals. To determine if the intervention reduces the incidence of central pain sensitisation after surgery using pressure Algometry (quantitative sensory testing) to measure pressure pain thresholds. To determine if the intervention is cost-effective by undertaking an analysis of health resource use. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients undergoing primary total hip replacement or primary total knee replacement for osteoarthritis at the Avon Orthopaedic Centre who are willing and able to provide fully-informed consent and complete the study questionnaires. |
|
E.4 | Principal exclusion criteria |
Patients undergoing revision joint replacement Patients undergoing joint replacement for a diagnosis other than osteoarthritis Patients under the age of 18 years. Patients with any medical co-morbidity that precludes spinal anaesthetic, regional blocks or the use of strong analgesics post-operatively. Diagnosis of severe dementia or psychiatric illness such that they are unable to complete the questionnaires or provide informed consent Patients undergoing stimulatenous bilateral joint replacement Patients who have been in the trial for a previous joint replacement Patients who are unable to understand English will be exclude because not all the validated questionnaires have been translated into languages other than English. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The WOMAC pain score at 12-months post-operative. |
|
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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | 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 | 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 | Yes |
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
|
When the last questionnaire is completed at 12-months after surgery. |
|
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 | 3 |
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 | 3 |