The Effect of Dexamethasone Administration Route and Local Anesthetic Concentration on Pain, Inflammatory Response, and Neuromonitoring in Children Undergoing Scoliosis Correction

NCT06789029 | Recruiting Phase 4 DMC

• 1 other identifier: 1/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Scoliosis correction surgery in children is a complex procedure with significant risks, including postoperative pain, inflammatory response, and potential neurological complications. Effective pain control and minimizing inflammation are critical for faster recovery and improved patient outcomes. Dexamethasone is commonly used as an adjuvant in regional anesthesia due to its anti-inflammatory effects and ability to prolong analgesia. However, limited research exists on the optimal route of dexamethasone administration (intravenous vs. perineural) and the best local anesthetic concentration for pain management, inflammatory response, and neuromonitoring during surgery. This study aims to compare the effects of different dexamethasone administration routes and local anesthetic concentrations on postoperative pain, inflammation (NLR, PLR), and neuromonitoring in pediatric scoliosis surgery. Results may improve regional anesthesia protocols, enhance patient safety, and offer valuable insights for clinical practice.

Conditions

Scoliosis Idiopathic Adolescent

Keywords

scoliosis; Neuromonitoring,; erector spinae plane block; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Time to first rescue opioid analgesia

  Time to first rescue opioid analgesia

  48 hours after surgery

Secondary Outcomes (14)

• intraoperative requirement for propofol

  durring surgery

• intraoperative requirement for remifentanil

  durring surgery

• MEP

  durring surgery

• Total opioid consumption

  48 after surgery

• NRS

  6 hours after surgery

Study Arms (2)

perineural Dexamethasone

ACTIVE COMPARATOR

Erector Spinae Plane Block with 0.2% ropivacaine with perineural 0.1mg/kg dexamethasne

Drug: perineural Dexamethasone

intravenous dexamethasne

ACTIVE COMPARATOR

Erector Spinae Plane Block with 0.2% ropivacaine with intravenous 0.1mg/kg dexamethasne

Drug: intravenous Dexamethasone

Interventions

perineural Dexamethasone DRUG

Erector Spinae Plane Block with 0.2% Ropivacaine + 0.1mg/kg perineural Dexamethasone

perineural Dexamethasone

intravenous Dexamethasone DRUG

Erector Spinae Plane Block with 0.2% Ropivacaine + 0.1mg/kg intravenous Dexamethasone

intravenous dexamethasne

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• included infection at the site of the regional block,
• coagulation disorders,
• immunodeficiency,
• American Society of Anesthesiologists (ASA) physical status of IV or higher,
• history of regular steroid medication.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 60-701, Poland

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Malgorzata Reysner, M.D. Ph.D.

CONTACT

+48608762068; mdomagalska@ump.edu.pl

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: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)