Osteoarthritis, Hip, Hip Osteoarthritis
Conditions
Brief summary
his study will test whether giving dexamethasone through a vein can improve pain control after total hip replacement surgery. Dexamethasone is commonly used to reduce nausea and may also help with pain, but it is not clear which dose works best. Patients will be randomly assigned to receive either no dexamethasone, 4 mg, or 8 mg, in addition to standard anesthesia and a nerve block (PENG block). The main goal is to see how long patients go without needing additional pain medication after surgery. The study will also look at pain levels, use of opioid painkillers, nausea and vomiting, blood sugar levels, and possible side effects.
Detailed description
Effective pain control after total hip arthroplasty (THA) remains a key component of perioperative care, as inadequate analgesia may delay mobilization, prolong hospital stay, and increase the need for opioids. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block, are increasingly used to improve postoperative pain management while preserving motor function. Dexamethasone administered intravenously is commonly used in perioperative care, primarily for the prevention of postoperative nausea and vomiting. In addition, it has been shown to prolong the duration of analgesia when used as an adjunct to regional anesthesia. However, there is still uncertainty regarding the optimal intravenous dose that provides clinically meaningful analgesic benefit without increasing the risk of adverse effects, particularly hyperglycemia. Previous studies have typically used doses ranging from 4 mg to 8 mg, but direct comparisons between these doses, as well as comparison with placebo, remain limited in patients undergoing THA. Furthermore, the potential dose-response relationship of intravenous dexamethasone in this specific surgical population has not been clearly established. This study is designed to address this knowledge gap by evaluating whether intravenous dexamethasone provides additional analgesic benefit in patients undergoing THA with PENG block, and whether higher doses result in improved outcomes compared to lower doses or no dexamethasone. The findings may help optimize perioperative analgesic strategies and support more evidence-based dosing of dexamethasone in orthopedic surgery.
Interventions
DRUGDexamethasone 4mg
Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 4 mg
DRUGPlacebo
Intravenous administration of 0.9% sodium chloride in a volume identical to active treatment, given after induction of anesthesia.
Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 8 mg
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Scheduled for elective total hip arthroplasty (THA) * Planned use of regional anesthesia including PENG block * American Society of Anesthesiologists (ASA) physical status I-III * Ability to understand the study procedures and provide written informed consent * Ability to assess pain using the Numeric Rating Scale (NRS)
Exclusion criteria
* Known hypersensitivity to dexamethasone or any component of the study medication * Chronic corticosteroid therapy or use of systemic steroids within 14 days prior to surgery * Active systemic infection or sepsis * Significant immunosuppression (e.g., chemotherapy, biological therapy) * Pregnancy or breastfeeding * Severe cognitive impairment or inability to reliably assess pain * Uncontrolled diabetes mellitus (e.g., HbA1c \> 8.5% or baseline blood glucose \> 200 mg/dL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Rescue Analgesia | 48 hours after surgery | Time from the end of surgery to the first administration of rescue analgesia (opioid) due to inadequate pain control (Numeric Rating Scale ≥ 4 or patient request). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | 6 hours after surgery | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) |
| Opioid Consumption | 48 hours after surgery | Total opioid consumption converted to morphine milligram equivalents (MME). |
| Incidence of Postoperative Nausea and Vomiting (PONV) | 24 hours after surgery | Occurrence of nausea and/or vomiting and need for antiemetic treatment. |
| Blood Glucose Levels | immidietly after surgery (0 hours after surgery) | Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone. |
Countries
Poland
Contacts
CONTACTMałgorzata Reysner, MD PhD
CONTACTTomasz Reysner, MD PhD
PRINCIPAL_INVESTIGATORJustyna Marszałek-Buko, MD
Poznan University of Medical Sciences
Outcome results
None listed