Poznan University of Medical Sciences
Poznan, 62-701, Poland
Location status: Recruiting
NCT Number: NCT07581470
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Poznan, 62-701, Poland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 4 mg
Other names: Dexamethasone sodium phosphate
Intravenous administration of 0.9% sodium chloride in a volume identical to active treatment, given after induction of anesthesia.
Other names: 0.9% sodium chloride
Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 8 mg
Other names: Dexamethasone sodium phosphate
Time frame: 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).
Time frame: 6 hours after surgery
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 12 hours after surgery
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 24 hours after surgery
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 48 hours after surgery
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Time frame: 48 hours after surgery
Total opioid consumption converted to morphine milligram equivalents (MME).
Time frame: 24 hours after surgery
Total opioid consumption converted to morphine milligram equivalents (MME).
Time frame: 24 hours after surgery
Occurrence of nausea and/or vomiting and need for antiemetic treatment.
Time frame: immidietly after surgery (0 hours after surgery)
Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.
Time frame: 6 hours after surgery
Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.
Time frame: 12 hours after surgery
Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.
Time frame: 24 hours after surgery
Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.
Contact information is provided by the study sponsor or research team.
Małgorzata Reysner, MD PhD
CONTACT
Tomasz Reysner, MD PhD
CONTACT
Poznan University of Medical Sciences
Other
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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