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Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

P

Poznan University of Medical Sciences (PUMS)

Status and phase

Not yet enrolling
Phase 4

Conditions

Scoliosis; Adolescence
Scoliosis
Scoliosis Idiopathic

Treatments

Drug: 0.9%NaCl
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT06789016
12/2024

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

DEXMEDETOIDINE
Active Comparator group
Description:
0.2% ropivacaine 0.5ml/kg+ 0.1ug/kg Dexamethasone for erector spinae plane block
Treatment:
Drug: Dexmedetomidine
CONTROL
Active Comparator group
Description:
0.2% ropivacaine 0.5ml/kg for erector spinae plane block
Treatment:
Drug: 0.9%NaCl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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