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Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block

4 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

90

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

3 månader till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Sham Block

0.2% ropivacaine for popliteal nerve block
Läkemedel: 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

Andra namn:
  • placebo
Aktiv komparator: Dexamethasone

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

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

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

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
time to the first need of opiate following the procedure
Tidsram: within 48 hours

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: within 48 hours

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

Samarbetspartners och utredare

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Sponsor

Poznan University of Medical Sciences

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 maj 2024

Primärt slutförande (Faktisk)

8 juli 2025

Avslutad studie (Faktisk)

8 juli 2025

Studieregistreringsdatum

Först inskickad

22 januari 2024

Först inskickad som uppfyllde QC-kriterierna

4 mars 2024

Första postat (Faktisk)

12 mars 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 18/2023

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