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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis, Hip; Hip Osteoarthritis
• Intervention / Treatment: Drug: Placebo; Drug: Dexamethasone 4mg; Drug: Dexamethasone 8mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Małgorzata Reysner, MD PhD; Phone Number: +48 (61) 8310122; Email: mreysner@ump.edu.pl
• Study Contact Backup: Name: Tomasz Reysner, MD PhD; Phone Number: +48 (61) 8310122; Email: mreysner@ump.edu.pl

Study Locations

• Poland
  • Poznan, Poland, 62-701
    • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 4 mg; Other Names: Dexamethasone sodium phosphate
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; Intravenous dexamethasone administered as a single dose after induction of anesthesia, at doses of 8 mg; Other Names: Dexamethasone sodium phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Justyna Marszałek-Buko, MD, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; dexamethasone 21-phosphate; Sodium Chloride
• Other Study ID Numbers: 3/2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No