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

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.

Study Overview

• Status: Completed
• Conditions: Hip Pain Chronic; Osteoarthritis, Hip; Hip Arthritis; Hip Arthropathy
• Intervention / Treatment: Drug: perineural Dexamethasone 4mg; Drug: intravenous Dexamethsone 4mg

Detailed Description

Total hip arthroplasty (THA) is a common orthopedic procedure associated with significant postoperative pain and inflammation, which can impact recovery and long-term outcomes. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block, have become increasingly popular for pain management in THA due to their ability to provide effective analgesia while preserving motor function.

Dexamethasone is frequently used as an adjuvant in regional anesthesia to prolong the duration of analgesia and reduce inflammation. However, there is limited evidence comparing the efficacy of different administration routes of dexamethasone (intravenous vs. perineural) in the context of PENG block. Additionally, understanding the impact of dexamethasone on postoperative pain, inflammatory markers, and overall patient recovery is crucial for optimizing clinical protocols.

This study is a prospective, randomized, double-blinded trial involving patients undergoing elective THA. Participants will be randomly assigned to two groups: the IV dexamethasone group or the perineural dexamethasone group. Both groups will receive standardized general anesthesia and PENG block with local anesthetic. Postoperative pain will be assessed using the NRS at various time intervals (e.g., 6, 12, 24, and 48 hours postoperatively) at rest and during movement. NLR and PLR will measure the inflammatory response from blood samples taken preoperatively and 24 hours postoperatively.

The primary outcome is time first to request rescue analgesia. Secondary outcomes include cumulative opioid consumption, length of hospital stay, and patient satisfaction. Safety and potential complications, such as local anesthetic systemic toxicity (LAST), will be closely monitored.

The results of this study may provide valuable insights into the optimal use of dexamethasone as an adjuvant in regional anesthesia for THA, potentially improving pain management, reducing opioid use, and enhancing postoperative recovery.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland, 60-701
    • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Perineural dexamethasone; PENG block + perineural dexamethasone	Drug: perineural Dexamethasone 4mg; PENG block with 20ml 0.2% ropivacaine + 4mg perineural Dexamethasone
Active Comparator: Intravenous dexamethasone; PENG block + intravenous dexamethasone	Drug: intravenous Dexamethsone 4mg; PENG block with 20ml 0.2% ropivacaine + 4mg intravenous Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue opioid analgesia	Time to first rescue opioid analgesia	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NLR	Neutrophil-to-lymphocyte ratio	48 hours after surgery
PLR	Platelet-to-lymphocyte ratio	48 hours after surgery
PLR	Platelet-to-lymphocyte ratio	12 hours after surgery
PLR	Platelet-to-lymphocyte ratio	24 hours after surgery
NLR	Neutrophil-to-lymphocyte ratio	12 hours after surgery
NLR	Neutrophil-to-lymphocyte ratio	24 hours after surgery
glucose	blood glucose level	24 hours after surgery
glucose	blood glucose level	48 hours after surgery
glucose	blood glucose level	12 hours after surgery
Total opioid consumption	Total opioid consumption (mg) converted to morphine milligram equivalents (MME)	48 hours after surgery
NRS	Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")	4 hours after surgery
NRS	Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")	8 hours after surgery
NRS	Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")	12 hours after surgery
NRS	Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")	24 hours after surgery
NRS	Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")	48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.	4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.	8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.	12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.	24 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.	48 hours after surgery
Nerve damage	Nerve damage assessment will be performed using the following grading scale: N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome	12 hours after surgery
Nerve damage	Nerve damage assessment will be performed using the following grading scale: N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome	24 hours after surgery
Nerve damage	Nerve damage assessment will be performed using the following grading scale: N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome	48 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Malgorzata Reysner, M.D. Ph.D., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: adjuvant; dexamethasone; PENG block; pericapsular nerve group block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 2/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No