Dexmedetomidine Vs Dexamethasone in Popliteal Nerve Block
Perineural Dexmedetomidine Vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
1 other identifier
interventional
90
1 country
1
Brief Summary
Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot 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 May 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
March 12, 2024
CompletedStudy Start
First participant enrolled
May 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedJanuary 21, 2025
January 1, 2024
11 months
January 22, 2024
January 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
time to the first need of opiate following the procedure
Time after surgery when the patient needs opiate for the first time
within 48 hours
Secondary Outcomes (13)
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
4 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
6 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
8 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
12 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
16 hours
- +8 more secondary outcomes
Study Arms (3)
Sham Block
PLACEBO COMPARATOR0.2% ropivacaine for popliteal nerve block
Dexamethasone
ACTIVE COMPARATOR0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block
Dexmedetomidine
ACTIVE COMPARATOR0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block
Interventions
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block
Eligibility Criteria
You may qualify if:
- children scheduled for foot/ankle surgery
- body weight \> 5kg
You may not qualify if:
- 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 CHAIR
Tomasz Kotwicki, Prof dr hab
Poznan University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2024
First Posted
March 12, 2024
Study Start
May 6, 2024
Primary Completion
March 31, 2025
Study Completion
April 30, 2025
Last Updated
January 21, 2025
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share