Dexamethasone for ESPB in Total Hip Arthroplasty

Efficacy of Perineural Dexamethasone to Prolong Anesthesia After Erector Spinae Plane Block for Total Hip Arthroplasty

Effect of adding Dexamethasone to Erector Spinae Plane Block in Patients undergoing Total Hip Arthroplasty

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis; Hip Arthritis; Hip Arthropathy
• Intervention / Treatment: Drug: 0.9%NaCl; Drug: Dexamethasone 4mg

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
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 61-701
      • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; 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: Control group; Ultrasound-guided ESPB - 20ml 0,2% ropivacaine + 2ml 0.9% NaCl	Drug: 0.9%NaCl; 20ml 0.2% Ropivacaine + 2.0ml 0.9% NaCl
Active Comparator: Dexamethasone; Ultrasound-guided ESPB - 20ml 0,2% ropivacaine + 4mg Dexamethasone	Drug: Dexamethasone 4mg; 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
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
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
Total Opioid Consumption	otal opiate consumption after surgery	48 hours after procedure
blood glucose	blood glucose levels	12 hours after surgery
blood glucose	blood glucose levels	24 hours after surgery
blood glucose	blood glucose levels	48 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Director: Malgorzata Resyner, MD PhD, Poznań University of Medical Science

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): July 18, 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: March 1, 2025

More Information

Terms related to this study

• Keywords: total hip arthroplasty; pain management; erector spinae plane block; perineural adjuvant
• 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: 10/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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