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

Osteoarthritis, Knee Clinical Trial

Official title:

The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612702
• Other study ID #: B-1102/121-006
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2012
• Last updated: May 21, 2013
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: May 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diagnosis of primary osteoarthritis, knee

• Scheduled for elective total knee arthroplasty

• Signed written informed consent

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Drug:
• Dexamethasone
Dexamethasone 10 mg intravenous administration

Locations

Country	Name	City	State
Korea, Republic of	Joint Reconstruction Center, Seoul National University Bundang Hospital	Seongnam-Si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Tae Kyun Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Nausea and Vomiting	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	within 72 hours after surgery	No
Secondary	Pain Level	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).	6 to 24 hours after surgery	No
Secondary	Wound Complication	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.	within 30 days after surgery	Yes