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Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

P

Poznan University of Medical Sciences (PUMS)

Status and phase

Completed
Phase 4

Conditions

Scoliosis; Adolescence
Scoliosis
Scoliosis Idiopathic

Treatments

Drug: Dexamethasone
Drug: 0.9%NaCl

Study type

Interventional

Funder types

Other

Identifiers

NCT06616220
11/2024

Details and patient eligibility

About

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

Full description

This study proposes to explore the effect of perineurial Dexamethasone on erector spinal plane block duration 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 Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

Enrollment

60 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, including a placebo group

DEXAMETHASONE
Active Comparator group
Description:
0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block
Treatment:
Drug: Dexamethasone
CONTROL
Placebo Comparator group
Description:
0.2% ropivacaine 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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