ClinicalTrials.gg
RecruitingNCT07581470Updated Nov 5, 2026

Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty

An interventional study of Dexamethasone 4mg and Placebo in Osteoarthritis, Hip and Hip Osteoarthritis, sponsored by Poznan University of Medical Sciences. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Updated Nov 5, 2026Title changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Osteoarthritis, Hip
  • Hip Osteoarthritis

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03

In context

Osteoarthritis, Hip

641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.

This study's planned enrollment of 198 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Scheduled for elective total hip arthroplasty (THA)
  • Planned use of regional anesthesia including PENG block
  • (ASA) physical status I-III
  • Ability to understand the study procedures and provide written
  • Ability to assess pain using the Numeric Rating Scale (NRS)

Exclusion criteria

Exclusion Criteria:

  • Known to dexamethasone or any component of the study medication
  • Chronic therapy or use of systemic steroids within 14 days prior to surgery
  • Active systemic infection or sepsis
  • Significant (e.g., chemotherapy, biological therapy)
  • Pregnancy or breastfeeding
  • Severe cognitive impairment or inability to reliably assess pain
  • Uncontrolled diabetes mellitus (e.g., > 8.5% or baseline blood glucose > 200 mg/dL)
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
198 participants (estimated)

Study arms

  • Placebo comparator
    Placebo (0 mg Intravenous Dexamethasone)

    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.

    Drug: Placebo

  • Active comparator
    Dexamethasone 4 mg Intravenous

    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.

    Drug: Dexamethasone 4mg

  • Active comparator
    Dexamethasone 8 mg Intravenous

    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.

    Drug: Dexamethasone 8mg

Interventions

  • Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 4 mg

    Also known as: Dexamethasone sodium phosphate

  • DrugPlacebo

    Intravenous administration of 0.9% sodium chloride in a volume identical to active treatment, given after induction of anesthesia.

    Also known as: 0.9% sodium chloride

  • Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 8 mg

    Also known as: Dexamethasone sodium phosphate

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 48 hours after surgery

Secondary outcomes

  1. Postoperative Pain Intensity

    Pain intensity at rest assessed using an 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain)

    Time frame: 6 hours after surgery

  2. Postoperative Pain Intensity

    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

  3. Postoperative Pain Intensity

    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

  4. Postoperative Pain Intensity

    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

  5. Opioid Consumption

    Total opioid consumption converted to morphine milligram equivalents (MME).

    Time frame: 48 hours after surgery

  6. Opioid Consumption

    Total opioid consumption converted to morphine milligram equivalents (MME).

    Time frame: 24 hours after surgery

  7. Incidence of Postoperative Nausea and Vomiting (PONV)

    Occurrence of nausea and/or vomiting and need for antiemetic treatment.

    Time frame: 24 hours after surgery

  8. Blood Glucose Levels

    Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.

    Time frame: immidietly after surgery (0 hours after surgery)

  9. Blood Glucose Levels

    Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.

    Time frame: 6 hours after surgery

  10. Blood Glucose Levels

    Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.

    Time frame: 12 hours after surgery

  11. Blood Glucose Levels

    Perioperative blood glucose measurements to assess the metabolic effect of dexamethasone.

    Time frame: 24 hours after surgery

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Jun 2027, 13 months after the start.

Of 200 non-industry interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 13 months is below that.

Counting every sponsor, half of 226 studies reached it within 29 months; a quarter within 14 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2026
First posted
May 12, 2026
StartActual
May 8, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jul 31, 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Title
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
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Title 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
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07581470
Responsible party
Sponsor
First posted
May 12, 2026
Start date
May 8, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Małgorzata Reysner, MD PhD
Contact
mreysner@ump.edu.pl
+48 (61) 8310122
Tomasz Reysner, MD PhD
Contact
mreysner@ump.edu.pl
+48 (61) 8310122
Justyna Marszałek-Buko, MD
principal investigator · Poznan University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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