Osteoarthritis, Knee
Conditions
Keywords
postoperative nausea and vomiting, postoperative pain
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.
Interventions
DRUGDexamethasone
Dexamethasone 10 mg intravenous administration
Sponsors
Tae Kyun Kim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Participant flow
Recruitment details
305 patients who were scheduled for unilateral total knee arthroplasty at Seoul National Bundang Hospital from April 2011 to December 2011 were recruited.
Pre-assignment details
14 patients were excluded before assignment. 5 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 4 had serious medical conditions such as renal failure, heary failure, 5 refused to participate
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone dexamethasone 10 mg administration 1 hour before surgery | 146 |
| Control No dexamethasone | 145 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 11 | 11 |
Baseline characteristics
| Characteristic | Total | Dexamethasone | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 263 Participants | 132 Participants | 131 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 14 Participants | 14 Participants |
| Age Continuous | 72 years STANDARD_DEVIATION 6.4 | 72 years STANDARD_DEVIATION 6.7 | 72 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment Korea, Republic of | 291 participants | 146 participants | 145 participants |
| Sex: Female, Male Female | 236 Participants | 117 Participants | 119 Participants |
| Sex: Female, Male Male | 55 Participants | 29 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 146 | 0 / 145 |
| serious Total, serious adverse events | 1 / 146 | 1 / 145 |
Outcome results
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
Time frame: within 72 hours after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone | Incidence of Nausea and Vomiting | 24 percentage of participant |
| Control | Incidence of Nausea and Vomiting | 40 percentage of participant |
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).
Time frame: 6 to 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone | Pain Level | 2.4 units on a scale | Standard Deviation 1 |
| Control | Pain Level | 4.0 units on a scale | Standard Deviation 2 |
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.
Time frame: within 30 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone | Wound Complication | 1 participant |
| Control | Wound Complication | 1 participant |