NCT06233565

Brief Summary

Effect of perineurial dexamethasone and dexmedetomidine on popliteal nerve block duration for pediatric, ankle or foot surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

February 9, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2025

Completed
Last Updated

July 11, 2025

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

January 22, 2024

Last Update Submit

July 8, 2025

Conditions

Foot Injuries and DisordersAnkle Injuries and Disorders

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: 6 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]

  • +4 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

0.2% ropivacaine for popliteal nerve block

Drug: 0.9%sodium chloride

Dexamethasone

ACTIVE COMPARATOR

0.2% ropivacaine + 0.1mg/kg Dexamethasone for popliteal nerve block

Drug: Dexamethasone

Dexmedetomidine

ACTIVE COMPARATOR

0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for popliteal nerve block

Drug: Dexmedetomidine

Interventions

0.9%sodium chlorideDRUG

administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block

Also known as: placebo
Placebo
DexamethasoneDRUG

administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block

Also known as: desamethasone
Dexamethasone
DexmedetomidineDRUG

administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the popliteal nerve block

Dexmedetomidine

Eligibility Criteria

Age3 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all children scheduled for ankle or foot surgery
  • aged \> 3 months \< 7 years

You may not qualify if:

  • age \< 3 months
  • age \> 7 years
  • infection at the site of the regional blockade
  • coagulation disorders
  • immunodeficiency
  • ASA= or \>4
  • steroid medication in regular use
  • chronic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

Location

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

Poznan, Wielkopolska, 61-545, Poland

Location

Related Publications (1)

  • Reysner T, Pietraszek P, Shadi M, Musielak B, Kowalski G, Daroszewski P, Reysner M. Effect of perineural dexamethasone versus dexmedetomidine as adjuvants to ropivacaine on analgesic duration in pediatric popliteal sciatic nerve blocks: a randomized, triple-blinded, placebo-controlled trial. Reg Anesth Pain Med. 2025 Oct 2:rapm-2025-107096. doi: 10.1136/rapm-2025-107096. Online ahead of print.

    PMID: 41043950DERIVED

MeSH Terms

Conditions

Foot InjuriesDiseaseAnkle Injuries

Interventions

Sodium ChlorideDexamethasoneCalcium DobesilateDexmedetomidine

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Tomasz Kotwicki, MD PhD

    Poznan University of Medical Sciences

    STUDY CHAIR

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

February 9, 2024

Primary Completion

July 8, 2025

Study Completion

July 8, 2025

Last Updated

July 11, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)