Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Knee Arthroplasty
NCT ID: NCT06470100
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
90 participants
INTERVENTIONAL
2024-08-13
2025-09-30
Brief Summary
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Detailed Description
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After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
Local anaesthesia's much lower toxicity threshold makes it essential for its safety. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research comparing intravenous and perineural dexamethasone and Dexmedetomidine use in orthopaedic surgeries. However, there is a massive lack of research regarding knee surgery and the Erector Spine Plane Block.
In this study, investigators compare perineural Dexamethasone and Dexmedetomidine.
The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control group
0.2% ropivacaine for erector spinae plane block
0.9% Sodium Chloride Injection
unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
Dexamethasone
0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block
Dexamethasone
unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
Dexmedetomidine
0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block
Dexmedetomidine
unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block
Interventions
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0.9% Sodium Chloride Injection
unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
Dexamethasone
unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
Dexmedetomidine
unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged \>18 years and \<100 years
* ASA physical status 1, 2 or 3.
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Poznan University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Malgorzata Domagalska, M.D. PhD.
Role: STUDY_CHAIR
Poznań University of Medical Science
Locations
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Poznan University of Medical Sciences
Poznan, Poznań, Poland
Countries
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Central Contacts
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Malgorzata Domagalska, M.D. Ph.D.
Role: CONTACT
Facility Contacts
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Other Identifiers
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107/24
Identifier Type: -
Identifier Source: org_study_id
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