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

NCT07581470 | Not Yet Recruiting

• 1 other identifier: 3/2026
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Hip; Hip Osteoarthritis

Outcome Measures

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).

  48 hours after surgery

Secondary Outcomes (11)

• Postoperative Pain Intensity

  6 hours after surgery

• Postoperative Pain Intensity

  12 hours after surgery

• Postoperative Pain Intensity

  24 hours after surgery

• Postoperative Pain Intensity

  48 hours after surgery

• Opioid Consumption

  48 hours after surgery

Study Arms (3)

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.

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.

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.

Drug: Dexamethasone 8mg

Interventions

Dexamethasone 4mg DRUG

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

Also known as: Dexamethasone sodium phosphate

Dexamethasone 4 mg Intravenous

Placebo DRUG

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

Placebo (0 mg Intravenous Dexamethasone)

Dexamethasone 8mg DRUG

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

Also known as: Dexamethasone sodium phosphate

Dexamethasone 8 mg Intravenous

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Dexamethasone; dexamethasone 21-phosphate; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Justyna Marszałek-Buko, MD

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Małgorzata Reysner, MD PhD

CONTACT

+48 (61) 8310122; mreysner@ump.edu.pl

Tomasz Reysner, MD PhD

CONTACT

+48 (61) 8310122; mreysner@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-04

Locations

PL (1)