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NCT Number: NCT07581470

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

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location status: Recruiting

Location contact

Malgorzata Reysner, M.D. Ph.D.

CONTACT

[email protected]

+48 61 873 83 03

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexamethasone 4mg

Drug

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

Other names: Dexamethasone sodium phosphate

Placebo

Drug

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

dexamethasone 8mg

Drug

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

Other names: Dexamethasone sodium phosphate

Primary outcomes

  1. Time to First Rescue Analgesia

    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).

Secondary outcomes

  1. Postoperative Pain Intensity

    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)

  2. Postoperative Pain Intensity

    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)

  3. Postoperative Pain Intensity

    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)

  4. Postoperative Pain Intensity

    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)

  5. Opioid Consumption

    Time frame: 48 hours after surgery

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

  6. Opioid Consumption

    Time frame: 24 hours after surgery

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

  7. Incidence of Postoperative Nausea and Vomiting (PONV)

    Time frame: 24 hours after surgery

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

  8. Blood Glucose Levels

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

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

  9. Blood Glucose Levels

    Time frame: 6 hours after surgery

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

  10. Blood Glucose Levels

    Time frame: 12 hours after surgery

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

  11. Blood Glucose Levels

    Time frame: 24 hours after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Małgorzata Reysner, MD PhD

CONTACT

[email protected]

+48 (61) 8310122

Tomasz Reysner, MD PhD

CONTACT

[email protected]

+48 (61) 8310122

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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