Acute and chronic pain following hip replacement surgery
Conditions
Interventions
Trade Name: Chirocaine (2.5mg/ml)
Product Name: Levobupivacaine
Pharmaceutical Form: Solution for injection
Trade Name: Chirocaine (5mg/ml)
Product Name: Levobupivacaine
Pharmaceutical Form: Solution
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria i)ASA class I-III American Society of Anesthesiologists classification system for all patients undergoing anaesthesia Class I - normal healthy patient Class II - patient with mild systemic disease Class III - patient with severe systemic disease ii)Age > 18yr =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria i)History of dementia ii)ASA class IV-V Class IV - patient with severe systemic disease which is a constant threat to life Class V - patient who is not expected to survive without the operation iii)History of allergy to any of the medications used in the study. iv)Inflammatory polyarthritis of a severity likely to compromise postoperative mobility v)Contraindication to regional anaesthesia vi)Patients suffering from severe hypotension such as cardiogenic or hypovolaemic shock or with a serious cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principle research question is to investigate the incidence and severity of chronic pain following administration of either a continuous lumbar plexus block or intravenous morphine in patients undergoing total hip replacement. The incidence of chronic pain will be assessed by the shortened form McGill pain questionnaire and an Oxford hip score questionnaire at 2 months, 6 months and 1 year post-operatively. ;Secondary Objective: The secondary research questions investigate is there any benefit of a lumbar plexus nerve block over intravenous morphine (given via a patient controlled analgesia [PCA] system) on post-operative in-hospital outcome following total hip replacement. Data will be collected on: i)Pain scores, using a visual analogue scale (VAS), will be assessed at 2,4 and 6 hours then 6 hourly for the first 48 hours post-operatively ii)Incidence of all complications associated with the analgesic technique in both groups iii)Incidence of nausea within the first 48 hours post-operatively in both groups iv)Morphine consumption within the first 48 hours post-operatively and total morphine usage (mg) from a patient controlled analgesia (PCA) system v)Number of days between surgery and hospital discharge vi)Length of time to first mobilization post-operatively and level of physiotherapy assistance required ;Primary end point(s): Primary end point: The incidence and severity of chronic pain, as assessed by the shortened form McGill pain questionnaire at 1 year following administration of either a continuous lumbar plexus block or intravenous morphine in patients undergoing primary hip arthroplasty. | — |
Countries
United Kingdom
Outcome results
None listed