Arthroplasty, Replacement, Knee
Conditions
Keywords
Postoperative pain
Brief summary
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization. The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.
Interventions
DRUGRopivacaine, Ketorolac, adrenaline
Infiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac
DRUGRopivacaine Ketorolac
Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients admitted consecutively to primary total knee arthroplasty. * Provided informed consent
Exclusion criteria
* Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception * Severe chronic neurogenic pain * Medical treated diabetes * Contraindications for spinal aesthesia and epidural analgesia * Known hypersensitivity towards study drugs * Rheumatoid arthritis * Treatment with narcotics * Treatment with antidepressants * Severe obesity BMI\>35 * Treatment with antacid * Not able to speak and understand Danish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analgésia consumption | 48 h |
Secondary
| Measure | Time frame |
|---|---|
| Time to discharge | — |
| Cytokine level | 48 h |
| Pain scores VAS | 72 h |
| Side-effects | 72 h |
Countries
Denmark
Outcome results
None listed