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NCT Number: NCT06789016

Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

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Key information

Conditions

Scoliosis Idiopathic Bone Diseases Musculoskeletal Diseases Scoliosis Scoliosis; Adolescence Spinal Curvatures Spinal Diseases

Age range

10 year–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, 61-545, Poland

About this study

This study proposes to explore the effect of perineurial Dexmedetomidine on the duration of erector spinal plane block for pediatric idiopathic scoliosis surgery.

Children need good analgesia after scoliosis surgery. 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 Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children scheduled for idiopathic scoliosis surgery
  • age >10 and <18 years

Exclusion criteria

  • age < 10 years
  • age < 18 years
  • infection at the site of the regional blockade
  • coagulation disorders
  • immunodeficiency
  • ASA= or >4
  • steroid medication in regular use

Treatment and study plan

Dexmedetomidine

Drug

administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block

Other names: DEX

0.9%NaCl

Drug

administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block

Other names: saline

Primary outcomes

  1. First need of opioid analgesia

    Time frame: 48 hours after surgery

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

Secondary outcomes

  1. Opioid consumption

    Time frame: 48 hours after surgery

    Total opiate consumption after surgery

  2. Numerical Rating Scale [range 0:10]

    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: 8 hours after surgery

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

  4. Numerical Rating Scale [range 0:10]

    Time frame: 12 hours after surgery

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

  5. Numerical Rating Scale [range 0:10]

    Time frame: 24 hours after surgery

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

  6. Numerical Rating Scale [range 0:10]

    Time frame: 48 hours after surgery

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

  7. Nerve damage [range 0-4]

    Time frame: 12 hours after surgery

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

  8. Nerve damage [range 0-4]

    Time frame: 24 hours after surgery

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

  9. Nerve damage [range 0-4]

    Time frame: 48 hours after surgery

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

  10. adverce effects

    Time frame: durring surgery

    nausea, vomitting, bradycardia, hypotension

  11. adverce effects

    Time frame: 48 hours after surgery

    nausea, vomitting, bradycardia, hypotension

  12. MEP

    Time frame: durring surgery

    motor evoced potentials

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Apr 13, 2026

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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