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Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block

4 november 2026 bijgewerkt door: Poznan University of Medical Sciences

Perineural Dexmedetomidine vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study is proposed to explore the effect of systemic Dexamethasone on the duration of popliteal block for analgesia after pediatric ankle surgery.

After ankle/foot surgery, children 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 in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, 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 use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.

The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

90

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Polen
    • Wielkopolska
      • Poznan, Wielkopolska, Polen, 61-545
        • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

3 maanden tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • children scheduled for foot/ankle surgery
  • body weight > 5kg

Exclusion Criteria:

  • infection at the site of the regional blockade
  • coagulation disorders
  • immunodeficiency
  • ASA= or >4
  • steroid medication in regular use

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Sham Block

0.2% ropivacaine for popliteal nerve block
Geneesmiddel: 0.9% Sodium chloride

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

Andere namen:
  • placebo
Actieve vergelijker: Dexamethasone

0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block
Geneesmiddel: 0.1mg/kg Dexamethasone

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

0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block
Geneesmiddel: 0.05ug/kg Dexmedetomidine

administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
time to the first need of opiate following the procedure
Tijdsspanne: within 48 hours

Time after surgery when the patient needs opiate for the first time
within 48 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tijdsspanne: 4 hours

The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
4 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tijdsspanne: 6 hours

The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
6 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tijdsspanne: 8 hours

The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
8 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tijdsspanne: 12 hours

The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
12 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tijdsspanne: 16 hours

The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
16 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tijdsspanne: 20 hours

The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
20 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tijdsspanne: 24 hours

The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
24 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tijdsspanne: 36 hours

The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
36 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tijdsspanne: 48 hours

The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
48 hours
Neutrophil-to-lymphocyte ratio
Tijdsspanne: 24 hours after surgery

Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample.
24 hours after surgery
Platelet-to-lymphocyte ratio
Tijdsspanne: 48 hours after surgery

The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions.
48 hours after surgery
Platelet-to-lymphocyte ratio
Tijdsspanne: 24 hours after surgery

The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions.
24 hours after surgery
Time to mobilization
Tijdsspanne: within 48 hours

Time after surgery when the patient moves the toe for the first time
within 48 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Poznan University of Medical Sciences

Onderzoekers

  • Studie stoel: Tomasz Kotwicki, Prof dr hab, Poznan University of Medical Sciences

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 mei 2024

Primaire voltooiing (Werkelijk)

8 juli 2025

Studie voltooiing (Werkelijk)

8 juli 2025

Studieregistratiedata

Eerst ingediend

22 januari 2024

Eerst ingediend dat voldeed aan de QC-criteria

4 maart 2024

Eerst geplaatst (Werkelijk)

12 maart 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

4 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 18/2023

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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