Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
This study was conducted to determine the efficacy of an additional preemptive, single, low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting (PONV), pain level, and the safety in terms of wound complications in patients managed with our antiemetic protocol based on Ramosetron following TKA.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty|
- Incidence of Nausea and Vomiting [ Time Frame: within 72 hours after surgery ] [ Designated as safety issue: No ]A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting
- Pain Level [ Time Frame: 6 to 24 hours after surgery ] [ Designated as safety issue: No ]A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain).
- Wound Complication [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured.
|Study Start Date:||April 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
dexamethasone 10 mg administration 1 hour before surgery
Dexamethasone 10 mg intravenous administration
No Intervention: Control
Postoperative pain and emesis can cause postoperative systemic complications and delay recovery and rehabilitation in patients following total knee arthroplasty (TKA). Furthermore, patients who suffered from severe postoperative pain and emesis tend to be dissatisfied with their surgical treatments. Although contemporary protocols to control perioperative pain and emesis after TKA have been reported to substantially reduce postoperative pain and emesis compared with traditional measures, pain and emesis after TKA remain to be a challenging issue for patients and health care providers. In our previous study, the use of Ramosetron was found to reduce postoperative emetic events, but the antiemetic effects by Ramosetron were incomplete. In search of a further antiemetic measure, we identified the use of dexamethasone as the additional measure fortifying our antiemetic protocol using Ramosetron.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612702
|Korea, Republic of|
|Joint Reconstruction Center, Seoul National University Bundang Hospital|
|Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707|
|Principal Investigator:||T K Kim, MD, PhD||Joint Recontruction Center, Seoul National University Bundang hospital|