Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
1 other identifier
interventional
90
1 country
1
Brief Summary
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis 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 Oct 2023
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
October 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 17, 2023
CompletedStudy Start
First participant enrolled
October 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2024
CompletedJanuary 21, 2025
January 1, 2024
11 months
October 11, 2023
January 17, 2025
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 (14)
Opioid consumption
48 hours
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
- +9 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATOR0.2% ropivacaine for erector spinae plane block
Dexamethasone
ACTIVE COMPARATOR0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block
Dexmedetomidine
ACTIVE COMPARATOR0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane block
Interventions
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block
Eligibility Criteria
You may qualify if:
- children scheduled for idiopathic scoliosis surgery
- age \>10 and \<18 years
You may not qualify if:
- age \< 10 years
- age \< 18 years
- infection at the site of the regional blockade
- coagulation disorders
- immunodeficiency
- ASA= or \>4
- steroid medication in regular use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
Poznan, Wielkopolska, 61-545, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tomasz Kotwicki, Prof.dr hab.
Poznan University of Medical Sciences
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
October 11, 2023
First Posted
October 17, 2023
Study Start
October 17, 2023
Primary Completion
September 24, 2024
Study Completion
November 5, 2024
Last Updated
January 21, 2025
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share