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NCT Number: NCT05887765

Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery

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Key information

Conditions

Ankle Disease Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Foot Deformities Foot Diseases Musculoskeletal Diseases Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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

After ankle or 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 anesthesia is particularly important in children due to the much lower toxicity threshold of local anesthetics. The use of an effective adjuvant, such as Dexamethasone, could allow for the use of a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is multiple research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a huge lack of research regarding children.

In this study, investigators compare different doses of systemic dexamethasone. Before the anesthesia, the patients receive dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg, and 0.2mg/kg.

The investigator's goal is to find a dexamethasone dose that is as low as possible but at the same time covers the need for good pain relief and fast recovery postoperatively.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children scheduled for ankle/foot 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

Treatment and study plan

Sodium Chloride 0.9% Inj

Drug

administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block

Other names: Placebo

0,1mg/kg Dexamethasone

Drug

administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

Other names: small dose

0,2mg/kg Dexamethasone

Drug

administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

Other names: large dose

Primary outcomes

  1. first need of opiate

    Time frame: 48 hours

    Time after surgery when the patient needs opiate for the first time

Secondary outcomes

  1. Opioid Consumption

    Time frame: 48 hours

    Total opiate consumption after surgery

  2. Pain score

    Time frame: 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery

    children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)

  3. Blood glucose

    Time frame: 24 and 48 hours after surgery

    Blood glucose every 24 hour during hospitalization

  4. NLR

    Time frame: 24 and 48 hours after surgery

    Neutrophil-to-lymphocyte ratio

  5. PLR

    Time frame: 24 and 48 hours after surgery

    Platelet-to-lymphocyte ratio

  6. Mobilisation

    Time frame: 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery

    Toe movement every 4 hours

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2023
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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