Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery
NCT ID: NCT06233617
Last Updated: 2024-04-29
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
2024-03-01
2025-04-01
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.
The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. 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 where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae 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
TRIPLE
Study Groups
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placebo
0.2% ropivacaine for erector spinae plane block
0.9% Sodium Chloride Injection
biliteral 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 4 Mg/mL Injectable Solution
biliteral 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 injection
biliteral 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
biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
Dexamethasone 4 Mg/mL Injectable Solution
biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
Dexmedetomidine injection
biliteral 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
* history of opioid abuse,
* infection of the puncture site,
* aged \<18 years and \>100 years
* ASA 4 and 5
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, PhD
Role: PRINCIPAL_INVESTIGATOR
Poznań University of Medical Sciences
Locations
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Poznan University of Medical Sciences
Poznan, Poznań, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3/2024
Identifier Type: -
Identifier Source: org_study_id
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