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Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block

4. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

90

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

3 Monate bis 18 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Sham Block

0.2% ropivacaine for popliteal nerve block
Arzneimittel: 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
Aktiver Komparator: Dexamethasone

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

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

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

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
time to the first need of opiate following the procedure
Zeitfenster: within 48 hours

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: within 48 hours

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Poznan University of Medical Sciences

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Mai 2024

Primärer Abschluss (Tatsächlich)

8. Juli 2025

Studienabschluss (Tatsächlich)

8. Juli 2025

Studienanmeldedaten

Zuerst eingereicht

22. Januar 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. März 2024

Zuerst gepostet (Tatsächlich)

12. März 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 18/2023

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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