Dexamethasone With Ropivacaine for PENG Block in Total Hip Arthroplasty

Pericapsular Nerve Group Block With 20 ml 0.2% Ropivacaine vs 10ml 0.2% Ropivacaine and Dexamethasone in Total Hip Arthroplasty: A Randomized Controlled Trial

Does adding Dexamethasone to the Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty reduce the dose of ropivacaine?

Study Overview

• Status: Completed
• Conditions: Hip Pain Chronic; Hip Osteoarthritis; Hip Arthritis
• Intervention / Treatment: Drug: Ropivacaine; Drug: Ropivacaine+Dexamethasone

Detailed Description

Hip arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

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

Contacts and Locations

Study Locations

• Poland
  • Poznań
    • Poznan, Poznań, Poland, 61-701
      • 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

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: Ropivacaine; Ultrasound-guided PENG block - 20ml 0,2% ropivacaine	Drug: Ropivacaine; Ultrasound-guided PENG block - 20ml 0,2% ropivacaine; Other Names: Pericapsular Nerve Group Block
Active Comparator: Ropivacaine + Dexamethasone; Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone	Drug: Ropivacaine+Dexamethasone; Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone; Other Names: Pericapsular Nerve Group Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue opioid analgesia	Time after surgery when the patient needs opiate for the first time	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale [range 0:10]	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)	4 hours after surgery
Numerical Rating Scale [range 0:10]	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)	8 hours after surgery
Numerical Rating Scale [range 0:10]	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)	12 hours after surgery
Numerical Rating Scale [range 0:10]	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)	24 hours after surgery
Numerical Rating Scale [range 0:10]	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)	48 hours after surgery
PLR	platelet-to-lymphocyte ratio	48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating	24 hours after surgery
Total Opioid Consumption	Total opiate consumption after surgery	48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating	4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating	8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating	12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating	48 hours after surgery
glucose	blood glucose level	24 hours after surgery
glucose	blood glucose level	48 hours after surgery
PLR	platelet-to-lymphocyte ratio	24 hours after surgery
Nerve damage [range 0-4]	Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)	12 hours after surgery
Nerve damage [range 0-4]	Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)	24 hours after surgery
Nerve damage [range 0-4]	Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)	48 hours after surgery
NLR	neutrophile-to-lymphocyte ratio	12 hours after surgery
NLR	neutrophile-to-lymphocyte ratio	24 hours after surgery
NLR	neutrophile-to-lymphocyte ratio	48 hours after surgery
PLR	platelet-to-lymphocyte ratio	12 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): November 7, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• 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; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine; Dexamethasone
• Other Study ID Numbers: 8/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available following study completion
• IPD Sharing Time Frame: Following study completion
• IPD Sharing Access Criteria: Eligible researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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