Pain relief after total hip replacement
Conditions
Interventions
Product Name: 0.2% Ropivacaine
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Infiltration
Product Name: Ketorolac
P
Sponsors
Epsom & St Helier's University Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria All patients undergoing total hip replacement at the South West London Elective Orthopaedic Centre Epsom from August 2009 to July 2010. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients will not be entered into the study if any of the following hold true:- Revision total hip replacement Habitual use of opioids Inflammatory joint disease Previous fracture of the affected hip Non-spinal anaesthesia – spinal analgesia provides longer lasting analgesia in total hip replacement and is practical to administer Psychiatric illness Neuromuscular deficit Allergic/contraindicated to the study medications Major systemic Illness (heart failure, renal failure, coagulopathy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research questions are Phase 1 1. What is the optimal combination of local anaesthetic/non steroidal anti inflammatory agents/adrenaline to inject in peri and post operative patients after total hip replacement to achieve maximum pain relief Phase2 1. For how long should the optimal combination be used after total hip replacement to achieve the quickest and most pain free post operative rehabilitation.;Secondary Objective: Phase 1 1. Assessing post operative mobility defined as ability to straight leg raise 30 minutes after first and second dose 2. Length of hospital stay 3. Incidence of heterotopic ossification in each group at 6 months post operative period 4. Incidence of adverse events 5. The requirement for opiates Phase 2 1) Time out of bed after surgery (Hours) 2) Time to stand after surgery (Hours) 3) Time to walking up a level ground for 10 yards (Hours) 4) Time to walk up and down the stairs (Hours) 5) Time to discharge (days) 6) Infection rate 7) Incidence of adverse events 8) The requirement for opiates;Primary end point(s): Phase 1 1. What is the optimal combination of local anaesthetic/non steroidal anti inflammatory agents/adrenaline to inject in peri and post operative patients after THR to achieve maximum pain relief Phase2 1. For how long should the optimal combination be used after total hip replacement to achieve the quickest and most pain free post operative rehabilitation. | — |
Countries
United Kingdom
Outcome results
None listed