Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Dexamethasone

• Registration Number: NCT01612702
• Lead Sponsor: Tae Kyun Kim

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Study First Submitted: 2012-06-03
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-06
• Results First Submitted: 2012-06-06
• Results First Submitted QC: 2013-04-12
• Status Verified: 2013-05
• Results First Posted: 2013-05-21
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

• Diagnosis of primary osteoarthritis, knee
• Scheduled for elective total knee arthroplasty
• Signed written informed consent

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Exclusion Criteria

• Refusing participate
• Contraindication to regional anesthesia
• Severe impairment of bowel motility
• administration of other antiemetic drug within 24hours before surgery
• systemic steroid within 24hours before surgery
• history of cardiovascular & respiratory disease
• renal & hepatic failure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	dexamethasone 10 mg administration 1 hour before surgery

Primary Outcome Measures

Name	Time	Method
Incidence of Nausea and Vomiting	within 72 hours after surgery	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

Secondary Outcome Measures

Name	Time	Method
Pain Level	6 to 24 hours after surgery	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	within 30 days after surgery	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.

Trial Locations

Locations (1)

Joint Reconstruction Center, Seoul National University Bundang Hospital; 🇰🇷 Seongnam-Si, Gyeonggi-do, Korea, Republic of