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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (0 mg Intravenous Dexamethasone) | Placebo Comparator | Participants receive placebo (0.9% sodium chloride) administered intravenously in a volume identical to active treatment after induction of anesthesia. All patients receive standard anesthesia, multimodal analgesia, and an ultrasound-guided PENG block with 20 mL of 0.2% ropivacaine. |
|
| Dexamethasone 4 mg Intravenous | Active Comparator | Participants receive 4 mg dexamethasone administered intravenously after induction of anesthesia. All patients receive standard anesthesia, multimodal analgesia, and an ultrasound-guided PENG block with 20 mL of 0.2% ropivacaine. |
|
| Dexamethasone 8 mg Intravenous | Active Comparator | Participants receive 8 mg dexamethasone administered intravenously after induction of anesthesia. All patients receive standard anesthesia, multimodal analgesia, and an ultrasound-guided PENG block with 20 mL of 0.2% ropivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 4mg | Drug | Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 4 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Rescue Analgesia | 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). | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 6 hours after surgery |
| Postoperative Pain Intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Małgorzata Reysner, MD PhD | Contact | +48 (61) 8310122 | mreysner@ump.edu.pl | |
| Tomasz Reysner, MD PhD | Contact | +48 (61) 8310122 | mreysner@ump.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Justyna Marszałek-Buko, MD | Poznan University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Recruiting | Poznan | 62-701 | Poland |
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| Placebo | Drug | Intravenous administration of 0.9% sodium chloride in a volume identical to active treatment, given after induction of anesthesia. |
|
|
| Dexamethasone 8mg | Drug | Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 8 mg |
|
|
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
| 12 hours after surgery |
| Postoperative Pain Intensity | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 24 hours after surgery |
| Postoperative Pain Intensity | Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) | 48 hours after surgery |
| Opioid Consumption | Total opioid consumption converted to morphine milligram equivalents (MME). | 48 hours after surgery |
| Opioid Consumption | Total opioid consumption converted to morphine milligram equivalents (MME). | 24 hours after surgery |
| Incidence of Postoperative Nausea and Vomiting (PONV) | Occurrence of nausea and/or vomiting and need for antiemetic treatment. | 24 hours after surgery |
| Blood Glucose Levels | Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone. | immidietly after surgery (0 hours after surgery) |
| Blood Glucose Levels | Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone. | 6 hours after surgery |
| Blood Glucose Levels | Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone. | 12 hours after surgery |
| Blood Glucose Levels | Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone. | 24 hours after surgery |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C004180 | dexamethasone 21-phosphate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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