Dexamethasone for PENG Block in Total Hip Arthroplasty

Pericapsular Nerve Group (PENG) Block with Ropivacaine Vs Ropivacaine and Dexamethasone in Total Hip Arthroplasty: a Randomized Controlled Trial

Effect of adding Dexamethasone to Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty

Study Overview

• Status: Completed
• Conditions: Hip Pain Chronic; Hip Osteoarthritis; Hip Arthropathy
• Intervention / Treatment: Drug: Ropivacaine 0.2% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution + 4mg 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 + 2ml 0.9% NaCl	Drug: Ropivacaine 0.2% Injectable Solution; 20ml 0.2% Ropivacaine + 2.0ml 0.9% NaCl
Active Comparator: Ropivacaine+Dexamethasone; Ultrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone	Drug: Ropivacaine 0.2% Injectable Solution + 4mg Dexamethasone; 20ml 0.2% Ropivacaine + 4mg Dexamethasone

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
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 levels	24 hours after surgery
glucose	blood glucose levels	48 hours after surgery
Nerve damage	Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome	12 hours after surgery
Nerve damage	Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome	24 hours after surgery
Nerve damage	Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome	48 hours after surgery
glucose	blood glucose levels	12 hours after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): February 10, 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

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; Pharmaceutical Solutions
• Other Study ID Numbers: 6/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

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