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
1 other identifier
interventional
60
1 country
1
Brief Summary
Effect of adding Dexamethasone to Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2024
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 24, 2024
CompletedStudy Start
First participant enrolled
August 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2025
CompletedMarch 24, 2025
March 1, 2025
5 months
June 17, 2024
March 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first rescue opioid analgesia
Time after surgery when the patient needs opiate for the first time
48 hours after surgery
Secondary Outcomes (17)
Total Opioid Consumption
48 hours after surgery
Numerical Rating Scale [range 0:10]
4 hours after surgery
Numerical Rating Scale [range 0:10]
8 hours after surgery
Numerical Rating Scale [range 0:10]
12 hours after surgery
Numerical Rating Scale [range 0:10]
24 hours after surgery
- +12 more secondary outcomes
Study Arms (2)
Ropivacaine
ACTIVE COMPARATORUltrasound-guided PENG block - 20ml 0,2% ropivacaine + 2ml 0.9% NaCl
Ropivacaine+Dexamethasone
ACTIVE COMPARATORUltrasound-guided PENG block - 20ml 0,2% ropivacaine + 4mg Dexamethasone
Interventions
20ml 0.2% Ropivacaine + 4mg Dexamethasone
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poznan University of Medical Sciences
Poznan, Poznań, 61-701, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Malgorzata Domagalska, M.D. Ph.D.
Poznań University of Medical Sciences
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
June 17, 2024
First Posted
June 24, 2024
Study Start
August 13, 2024
Primary Completion
January 15, 2025
Study Completion
February 10, 2025
Last Updated
March 24, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share