Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Hip Arthroplasty
1 other identifier
interventional
30
1 country
1
Brief Summary
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for hip arthroplasty
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2024
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
January 22, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedStudy Start
First participant enrolled
April 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedApril 29, 2024
April 1, 2024
12 months
January 22, 2024
April 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
first need of opiate
Time after surgery when the patient needs opiate for the first time
48 hours after surgery
Secondary Outcomes (9)
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]
16 hours after surgery
- +4 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATOR0.2% ropivacaine for erector spinae plane block
Dexamethasone
EXPERIMENTAL0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block
Dexmedetomidine
EXPERIMENTAL0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block
Interventions
unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block
Eligibility Criteria
You may qualify if:
- patients undergoing primary hip arthroplasty
- aged \>18 years and \<100 years
- ASA physical status 1, 2 or 3.
You may not qualify if:
- if they refused to participate,
- had a history of opioid abuse,
- had an infection of the site of needle puncture,
- were less than 18 years of age,
- were postponed as having ASA 4 or 5,
- had an allergy to any of the drugs used in the study,
- renal failure (estimated glomerular filtration rate \<15ml/min/1.73m2),
- liver failure,
- known or suspected coagulopathy,
- pre-existing anatomical or neurological disorders in the lower extremities,
- intellectual disability with problems in pain evaluation,
- severe psychiatric illness.
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
Katarzyna Wieczorowska-Tobis, Prof.dr hab.
Poznań University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2024
First Posted
January 31, 2024
Study Start
April 10, 2024
Primary Completion
March 30, 2025
Study Completion
May 30, 2025
Last Updated
April 29, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share