Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

NCT06616220 | Completed Phase 4

• 1 other identifier: 11/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scoliosis; Scoliosis Idiopathic; Scoliosis; Adolescence

Outcome Measures

Primary Outcomes (1)

• First need of opioid analgesia

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

  48 hours after surgery

Secondary Outcomes (13)

• Opioid consumption

  48 hours after procedure

• Numerical Rating Scale [range 0:10]

  4 hours after surgery

• Numerical Rating Scale [range 0:10]

  8 hours after surgery

• Numerical Rating Scale [range 0:10]

  12 hours after surgery

• Numerical Rating Scale [range 0:10]

  24 hours after surgery

Study Arms (2)

DEXAMETHASONE

ACTIVE COMPARATOR

0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block

Drug: Dexamethasone

CONTROL

PLACEBO COMPARATOR

0.2% ropivacaine for erector spinae plane block

Drug: 0.9%NaCl

Interventions

Dexamethasone DRUG

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

Also known as: Dexaethasone

DEXAMETHASONE

0.9%NaCl DRUG

0.9% NaCl

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

CONTROL

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

Poznan, Wielkopolska, 61-545, Poland

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: October 1, 2024
• Primary Completion: October 7, 2025
• Study Completion: October 7, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)