Osteoarthritis, HipNCT07581470
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty: A Randomized Double-Blind Trial
A study testing Dexamethasone 4mg and Dexamethasone 8mg in people with Osteoarthritis, Hip and Hip Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis, Hip, Hip Osteoarthritis
- What is being tested?
- Dexamethasone 4mg and Dexamethasone 8mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 sitePoland
- Study dates
- 8 May 2026to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Osteoarthritis, Hip, Hip Osteoarthritis
- Being tested
- Dexamethasone 4mg, Placebo, Dexamethasone 8mg
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4mgDrug
Also called Dexamethasone sodium phosphate
Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 4 mg
PlaceboDrug
Also called 0.9% sodium chloride
Intravenous administration of 0.9% sodium chloride in a volume identical to active treatment, given after induction of anesthesia.
Dexamethasone 8mgDrug
Also called Dexamethasone sodium phosphate
Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 8 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo |
| 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. Receives: Drug: Dexamethasone 4mg |
| 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. Receives: Drug: Dexamethasone 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours after surgery
Secondary outcomes (11)
Postoperative Pain Intensity
Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)
Measured: 6 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)
Measured: 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)
Measured: 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)
Measured: 48 hours after surgery
Opioid Consumption
Total opioid consumption converted to morphine milligram equivalents (MME).
Measured: 48 hours after surgery
Opioid Consumption
Total opioid consumption converted to morphine milligram equivalents (MME).
Measured: 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting (PONV)
Occurrence of nausea and/or vomiting and need for antiemetic treatment.
Measured: 24 hours after surgery
Blood Glucose Levels
Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.
Measured: immidietly after surgery (0 hours after surgery)
Blood Glucose Levels
Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.
Measured: 6 hours after surgery
Blood Glucose Levels
Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.
Measured: 12 hours after surgery
Blood Glucose Levels
Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start8 May 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justyna Marszałek-Buko, MD, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581470
- Sponsor's protocol ID
- 3/2026
- Status last verified
- Apr 2026
- First submitted
- 6 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No