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Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06616220
Enrollment
60
Registered
2024-09-27
Start date
2024-10-01
Completion date
2025-10-07
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence

Brief summary

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

Detailed 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.

Interventions

DRUGDexamethasone

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

0.9% NaCl

Sponsors

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
First need of opioid analgesia48 hours after surgeryTime after surgery when the patient needs opiate for the first time

Secondary

MeasureTime frameDescription
Opioid consumption48 hours after procedureTotal opiate consumption after surgery
Numerical Rating Scale [range 0:10]4 hours after surgeryNRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Nerve damage [range 0-4]12 hours after surgeryNerve 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)
glucose12 hours after surgeryblood glucose level
MEPdurring surgeryMotor-Evoced-Potentials

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026