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Completed

NCT Number: NCT06233565

Dexamethasone vs. Dexmedetomidine for Popliteal Nerve Block in Pain Management After Pediatric Ankle and Foot Surgery

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

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Key information

Conditions

Foot Injuries and Disorders Ankle Injuries Ankle Injuries and Disorders Disease Foot Injuries Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

3 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences, Poznan, Poznań, Poland

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About this study

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

After scoliosis 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 essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

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

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

0.9%sodium chloride

Drug

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

Other names: placebo

Dexamethasone

Drug

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

Other names: desamethasone

Dexmedetomidine

Drug

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

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. Numerical Rating Scale [range 0:10]

    Time frame: [Time Frame: 4 hours after surgery]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  3. Numerical Rating Scale [range 0:10]

    Time frame: [Time Frame: 6 hours after surgery]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  4. Numerical Rating Scale [range 0:10]

    Time frame: [Time Frame: 8 hours after surgery]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  5. Numerical Rating Scale [range 0:10]

    Time frame: [Time Frame: 12 hours after surgery]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  6. Numerical Rating Scale [range 0:10]

    Time frame: [Time Frame: 24 hours after surgery]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  7. Numerical Rating Scale [range 0:10]

    Time frame: [Time Frame: 48 hours after surgery]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

  8. NLR

    Time frame: 24 and 48 hours after surgery

    Neutrophil-to-lymphocyte ratio

  9. PLR

    Time frame: 24 and 48 hours after surgery

    Platelet-to-lymphocyte ratio

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2024
Registry last updated
Jul 11, 2025

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

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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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