Pain, Postoperative
Conditions
Keywords
Hip Arthroplasty, Treatment Outcome, Local Anesthesia
Brief summary
The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.
Interventions
DRUGRopivacaine, Ketorolac and Adrenalin
The local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg is given 10 and 22 hours after the operation. The medicine solution is administrated in a catheter, which is placed in the hip at the end of the operation.
DRUGPlacebo
This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, which is placed in the hip at the end of the operation.
Sponsors
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for an uncemented unilateral Total Hip Replacement because of osteoarthritis * Willingness and possibility to follow the instructions of the study * 18 years or older * written informed consent and authority after it has been read and understood.
Exclusion criteria
* Operation with anterior approach or using navigation * Do not understand or speech danish * Can not use the pain-score Numerical Rating Scale (NRS) * Special indications for Total Hip Replacement * Anaesthetized in general anaesthesia where a tube is demanded * Daily use of strong opioids, based on the investigators assessment * Fertile women * ASA-score: 3 and 4 * Known allergy against the standardized pain treatment, the study drugs and placebo, Ropivacaine, Ketorolac, Adrenalin. * Treatment with Lithium, Dihydroergotamin, full anticoagulant treatment or MAO-inhibitor * Following illness: * Active gastric ulcer or earlier gastrointestinal bleeding, ulceration or perforation of any kind. * Suspicions of manifest gastrointestinal bleeding and/or cerebrovascular bleeding * Haemorrhagic diathesis * Coagulation disorder * Severe thrombocytopenia * Severe heart insufficiency * Severe risk of postoperative bleeding or delayed haemostatic * Myocardium hypertrophy or ischaemic heart disease * Hypertension * Hypovolemics * Anhydration * angiooedema * Asthma * Bronchospasm * Severe liver insufficiency * Rhinostenosis because of polyostotic * Narrow-angled glaucoma * Phaeochromocytoma * Low plasm-potassium * Thyreotoxicosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score | 24 hours |
| Opioid Consumption | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative Nausea and Vomiting (PONV) | 3 days |
| Pain score | 7 days |
| Physical function | 2 month |
| Fatigue | 3 days |
| Opioid consumption | 3 days |
Countries
Denmark
Outcome results
None listed