Phase 4
Completed N=42
Dexamethasone and Pain Following Total Knee Arthroplasty
Source: ClinicalTrials.gov NCT02271698 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Change in Visual Analogue Pain Score — 3.09; 4.80; 3.56; 5.5 units on a scale — p=0.052
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is three fold. First to determine the ideal dose of dexamethasone intraoperatively that will reduce acute pain and opioid consumption. Second determine if dexamethasone at the time of surgery reduces chronic pain following total knee arthroplasty and finally determine if a pro-inflammatory environment makes patients susceptible to chronic pain after surgery and can dexamethasone alter this environment. Patients undergoing total knee arthroplasty will be randomized to four groups ( 0mg, 6mg, 12mg and 24mg dexamethasone) and assessments will be made of acute and chronic pain and quality of life measures. Blood samples will be drawn to assess Interleukin levels and for Macrophage sorting. For the primary efficacy endpoint of reduction of opioid consumption over 24 hours after surgery the dexamethasone regimen group will be compared to standard of care group using t-test. For comparisons of the secondary efficacy endpoints, t-test, Chi-square test and Fisher's Exact test will be used. Risks of this study include the risks of venipuncture and intravenous dexamethasone administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Analogue Pain Score |
3.09; 4.80; 3.56; 5.5; 4.36; 6.50 | 0.052 |
| PRIMARY Change in Opioid Consumption |
21.10; 22.20; 11.77; 33.50; 42.24; 27.24 | 0.181 |
| SECONDARY Change in Functional Status as Measured by Western Ontario and McMaster Universities Osteoarthritis Index |
25; 29.5; 42; 30; 17; 32 | — |
| SECONDARY Change in Chronic Pain as Measured by Brief Pain Inventory Questionnaire |
5; 5; 5; 4; 1; 0.5 | — |
| SECONDARY Change in Functional Status as Measured by Brief Pain Inventory Questionnaire |
5; 5; 5; 4; 0; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled to undergo unilateral total knee arthroplasty.
- American Society of Anesthesiology (ASA) Physical Class 1-3.
- BMI 1.8), comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.
Data sourced from ClinicalTrials.gov (NCT02271698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.