Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery
1 other identifier
interventional
90
1 country
1
Brief Summary
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 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
January 22, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedApril 29, 2024
April 1, 2024
1 year
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
Secondary Outcomes (9)
Opioid consumption
48 hours
Numerical Rating Scale [range 0:10]
Time Frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Time Frame: 16 hours after surgery
- +4 more secondary outcomes
Study Arms (3)
placebo
PLACEBO COMPARATOR0.2% ropivacaine for erector spinae plane block
Dexamethasone
ACTIVE COMPARATOR0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block
Dexmedetomidine
ACTIVE COMPARATOR0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block
Interventions
biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
biliteral 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 posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region,
- aged \>18 years and \<100 years
- ASA physical status 1, 2 or 3.
You may not qualify if:
- refuse to participate,
- history of opioid abuse,
- infection of the puncture site,
- aged \<18 years and \>100 years
- ASA 4 and 5
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
- PRINCIPAL INVESTIGATOR
Malgorzata Domagalska, PhD
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
March 1, 2024
Primary Completion
March 1, 2025
Study Completion
April 1, 2025
Last Updated
April 29, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share