Primary hip arthroplasty Musculoskeletal Diseases Primary hip arthroplasty
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients fit to undergo elective primary hip replacement at Chapel Allerton Hospital 2. Patients who are able to give informed consent 3. American Society of Anesthesiologists (ASA) 1-3
Exclusion criteria
Exclusion criteria: 1. Any patient already taking opioid analgesics or non-steroidal anti-inflammatory drugs (NSAID) 2. Allergy/sensitivity to local anaesthetics agents 3. Allergy/sensitivity to NSAIDs 4. Allergy/sensitivity to adrenaline 5. Patients taking anti-coagulant medication 6. Severe liver disease 7. Severely impaired renal function 8. Severe heart failure 9. Active cerebrovascular bleeding 10. Severe coagulation disorders 11. Severe asthma or previous bronchospasm with NSAIDs 12. Porphyria 13. Active peptic ulcer disease or acute gastrointestinal (GI) bleed 14. Any patient unable to consent or understand the pump function 15. Bilateral hip replacements 16. Pregnancy/lactation 17. Patients already enrolled in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A 30% reduction in the number of patients requiring opiate analgesia in the 48 hours post-operative period in the treatment group compared to the placebo group. 1. Pain is measured using a 10-point Visual Analogue Score (VAS) 2. The case report file for each study participant includes data collection on pain scores, opiate and other analgesia requirements and anti-emetic use. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain scores postoperatively as measured using a 100mm Visual Analogue Score (VAS) 2. Time to first mobilisation in hours 3. Time to independent mobilisation in hours 4. Time to fulfill discharge criteria in days 5. Time to hospital discharge in days 6. Urinary retention post operatively indicated by requirement for urinary catheter 7. Deep vein thrombosis (DVT) / pulmonary embolism (PE) rate at up to outpatient follow up (6-12 weeks post operation) 8. Side effects and general medical complications | — |
Countries
United Kingdom