drugset / Trial / NCT01604382
Early Mobilization After Total Knee Arthroplasty
RandomizedParallel-groupDouble-blindTreatment
Summary
Patients undergoing elective total knee arthroplasty are randomized to either intrathecal anesthesia, wound infiltration with local anesthetics and standardized postoperative care (NA = neuraxial anesthesia) or general anesthesia, intraoperative glucocorticoids with accelerated postoperative care principles (GA). The study hypothesis is that GA would reduce length-of-hospital stay. Outcome variables are postoperative nausea and vomiting, mobilization rate, pain, requirement of analgesics, and length-of-hospital stay.
Timeline
- Start
- 2008-09
- Primary completion
- 2009-05
- Completion
- 2010-06
Publications
- Background Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.
- Molt M, Harsten A, Toksvig-Larsen S. The effect of tourniquet use on fixation quality in cemented total knee arthroplasty a prospective randomized clinical controlled RSA trial. Knee. 2014 Mar;21(2):396-401. doi: 10.1016/j.knee.2013.10.008. Epub 2013 Oct 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 12.5 mg | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 15 mg | Intrathecal |
| Subject | Propofol | Small molecule | 5 ug/ml | — |
| Subject | Propofol | Small molecule | 0.8 mg | — |
| Subject | Propofol | Small molecule | 2.5 mg | — |
| Subject | Remifentanil | Small molecule | 5 ng/ml | — |