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

The Use of a Single, Low-dose Dexamethasone in 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 Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Actual): 291
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
      • Joint Reconstruction Center, Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; dexamethasone 10 mg administration 1 hour before surgery	Drug: Dexamethasone; Dexamethasone 10 mg intravenous administration
No Intervention: Control; No dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tae Kyun Kim
• Investigators: Principal Investigator: T K Kim, MD, PhD, Joint Recontruction Center, Seoul National University Bundang hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 3, 2012
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (Estimate): June 6, 2012

Study Record Updates

• Last Update Posted (Estimate): May 27, 2013
• Last Update Submitted That Met QC Criteria: May 21, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: postoperative pain; postoperative nausea and vomiting
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: B-1102/121-006