Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring postoperative nausea and vomiting, postoperative pain
Eligibility Criteria
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
Sites / Locations
- Joint Reconstruction Center, Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dexamethasone
Control
Arm Description
dexamethasone 10 mg administration 1 hour before surgery
No dexamethasone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01612702
Brief Title
Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
Official Title
The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tae Kyun Kim
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
postoperative nausea and vomiting, postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
dexamethasone 10 mg administration 1 hour before surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
No dexamethasone
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 10 mg intravenous administration
Primary Outcome Measure Information:
Title
Incidence of Nausea and Vomiting
Description
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
Time Frame
within 72 hours after surgery
Secondary Outcome Measure Information:
Title
Pain Level
Description
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).
Time Frame
6 to 24 hours after surgery
Title
Wound Complication
Description
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.
Time Frame
within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T K Kim, MD, PhD
Organizational Affiliation
Joint Recontruction Center, Seoul National University Bundang hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint Reconstruction Center, Seoul National University Bundang Hospital
City
Seongnam-Si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
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