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
1 other identifier
interventional
60
1 country
1
Brief Summary
Does adding Dexamethasone to the Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty reduce the dose of ropivacaine?
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 Nov 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
November 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedJuly 11, 2025
December 1, 2024
5 months
June 17, 2024
July 8, 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 (22)
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
- +17 more secondary outcomes
Study Arms (2)
Ropivacaine
ACTIVE COMPARATORUltrasound-guided PENG block - 20ml 0,2% ropivacaine
Ropivacaine + Dexamethasone
ACTIVE COMPARATORUltrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone
Interventions
Ultrasound-guided PENG block - 20ml 0,2% ropivacaine
Ultrasound-guided PENG block - 10ml 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 Reysner, 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
November 7, 2024
Primary Completion
March 31, 2025
Study Completion
April 30, 2025
Last Updated
July 11, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Following study completion
- Access Criteria
- Eligible researchers
Individual participant data will be available following study completion