Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

NCT ID: NCT06616220

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-10-07

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.

Conditions

Scoliosis; Scoliosis Idiopathic; Scoliosis; Adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DEXAMETHASONE

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

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

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

CONTROL

0.2% ropivacaine for erector spinae plane block

Group Type: PLACEBO_COMPARATOR

0.9%NaCl

Intervention Type: DRUG

0.9% NaCl

Interventions

Dexamethasone

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

Intervention Type: DRUG

0.9%NaCl

0.9% NaCl

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Poznan, Wielkopolska, Poland

Countries

Poland

Other Identifiers

11/2024

Identifier Type: -

Identifier Source: org_study_id