Osteoarthritis of the hip and knee joints
Conditions
Interventions
Trade Name: Levobupivacaine
Product Name: Levobupivacaine
Pharmaceutical Form: Injection*
Trade Name: Morphine Sulphate
Product Name: Morphine Sulphate
Pharmaceutical Form: Injection*
Sponsors
Greenpark Health Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 85. People with learning needs and communication disability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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?;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 | — |
Countries
United Kingdom
Outcome results
None listed