DEXRAR: DEXamethasone in Revision ARthroplasty

Launched by DANIEL HÄGI-PEDERSEN · Aug 25, 2016

Keywords

ClinConnect Summary

The DEXRAR clinical trial is studying the effects of a medication called dexamethasone on pain relief after a specific type of surgery known as revision total knee arthroplasty (TKA), which is when a doctor replaces parts of a knee joint that has already been operated on. The trial aims to find out if giving dexamethasone in combination with other pain medications can help manage pain better than just using a saltwater solution. The researchers will compare two groups of patients: one group will receive dexamethasone through an IV, and the other group will receive the saltwater solution, without either the patients or the doctors knowing which group they are in to ensure fairness in the results.

To be eligible to participate, patients need to be over 18 years old and scheduled for a revision TKA. They should be in fairly good health, with a specific measure of body weight and without any serious medical conditions that could interfere with the study. Participants can expect to receive either the study medication or the placebo during their surgery and will be monitored closely for any effects on their pain levels and overall safety. This trial is currently looking for around 108 patients to take part, and their contributions could help improve pain management strategies for future patients undergoing similar surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Scheduled for unilateral, revision-TKA: Total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s).
• • Age \> 18
• • American Society of Anesthesiologists (ASA) physical status classification system ASA 1- 3.
• • Body mass index (BMI) \> 18 and \< 45
• • Women in the fertile age (i.e. until one year after menopause) must have negative urine human chorionic gonadotropin (HCG) pregnancy test
• • Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.
• Exclusion Criteria:
• • Patients who cannot cooperate with the trial.
• • Concomitant participation in another trial involving medication
• • Patients who cannot understand or speak Danish.
• • Patients with allergy to medicines used in the trial.
• • Patients with daily use of methadone.
• • Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF \< 60 ml/kg/1,73m2), known thrombocytopenia (\<100 mia/L)
• • Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement.