Skip to main content
OpenTrials
Completed

NCT Number: NCT01612702

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Nausea Neurologic Manifestations Osteoarthritis Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Rheumatic Diseases Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 10 mg intravenous administration

Primary outcomes

  1. Incidence of Nausea and Vomiting

    Time frame: 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 outcomes

  1. Pain Level

    Time frame: 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).

  2. Wound Complication

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tae Kyun Kim

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jun 6, 2012
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.