The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Total Hip Arthroplasty

NCT06789328 | Completed Phase 4

• 1 other identifier: 2/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of the dexamethasone administration route (intravenous vs. perineural) on postoperative pain, inflammatory response, and clinical outcomes in patients undergoing total hip arthroplasty (THA) with a pericapsular nerve group (PENG) block. The primary outcome is the intensity of postoperative pain measured using the numerical rating scale (NRS) at rest and during movement. Secondary outcomes include the inflammatory response assessed by neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, and patient satisfaction. The findings from this study may contribute to optimizing anesthesia protocols and improving postoperative recovery in patients undergoing THA.

Conditions

Osteoarthritis, Hip; Hip Pain Chronic; Hip Arthropathy; Hip Arthritis

Keywords

pericapsular nerve group block; PENG block; adjuvant; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Time to first rescue opioid analgesia

  Time to first rescue opioid analgesia

  48 hours after surgery

Secondary Outcomes (23)

• Total opioid consumption

  48 hours after surgery

• NRS

  4 hours after surgery

• NRS

  8 hours after surgery

• NRS

  12 hours after surgery

• NRS

  24 hours after surgery

Study Arms (2)

Perineural dexamethasone

ACTIVE COMPARATOR

PENG block + perineural dexamethasone

Drug: perineural Dexamethasone 4mg

Intravenous dexamethasone

ACTIVE COMPARATOR

PENG block + intravenous dexamethasone

Drug: intravenous Dexamethsone 4mg

Interventions

perineural Dexamethasone 4mg DRUG

PENG block with 20ml 0.2% ropivacaine + 4mg perineural Dexamethasone

Perineural dexamethasone

intravenous Dexamethsone 4mg DRUG

PENG block with 20ml 0.2% ropivacaine + 4mg intravenous Dexamethasone

Intravenous dexamethasone

Eligibility Criteria

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

You may qualify if:

• patients scheduled for total hip arthroplasty
• patients aged \>65 and \<100 years
• patients able to provide informed consent
• patients able to reliably report symptoms to the research team

You may not qualify if:

• inability to provide first-party consent due to cognitive impairment or a language barrier
• infection at the site of the regional block,
• coagulation disorders,
• immunodeficiency,
• American Society of Anesthesiologists (ASA) physical status of IV or higher,
• history of regular steroid medication.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 60-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

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

Study Officials

• Malgorzata Reysner, M.D. Ph.D.

  Poznań University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 11, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-01

Locations

PL (1)