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

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis Idiopathic Adolescent
• Intervention / Treatment: Drug: perineural Dexamethasone; Drug: intravenous Dexamethasone

Detailed Description

Scoliosis correction surgery in children is a complex procedure associated with a significant risk of postoperative pain, inflammatory response, and potential neurological complications. Ensuring optimal pain control and minimizing adverse inflammatory responses is crucial for shortening the recovery period, improving patient comfort, and reducing the risk of long-term complications. In clinical practice, dexamethasone is frequently used as an adjuvant in regional anesthesia techniques due to its anti-inflammatory properties and its potential to prolong the analgesic effect.

Although the use of dexamethasone as an adjuvant in regional anesthesia is well known, there is limited research focusing on the impact of its route of administration (local versus intravenous) and the optimal concentration of local anesthetic agents on the effectiveness of pain control, inflammatory response, and neuromonitoring parameters during surgical procedures in children. Understanding these aspects is particularly important in complex procedures such as scoliosis correction surgery, where precise neurological function monitoring is essential for patient safety.

The objective of the proposed study is to evaluate the impact of different dexamethasone administration routes (intravenous and perineural) and varying concentrations of local anesthetic agents on postoperative pain, inflammatory response (measured using NLR and PLR indices), and neuromonitoring parameters in children undergoing scoliosis correction surgery. The findings from this study may contribute to the development of more effective and safer regional anesthesia and analgesia protocols for this patient group.

Conducting this study will provide new insights into the optimization of anesthesia in pediatric spinal surgery, potentially leading to improved treatment outcomes and patient safety, as well as valuable data for clinical practice regarding the selection of anesthetic strategies.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Malgorzata Reysner, M.D. Ph.D.; Phone Number: +48608762068; Email: mdomagalska@ump.edu.pl

Study Locations

• Poland
  • Poznan, Poland, 60-701
    • Recruiting
    • Poznan University of Medical Sciences
    • Contact: Malgorzata Reysner, M.D. Ph.D.; Phone Number: +48 608762068; Email: mdomagalska@ump.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: perineural Dexamethasone; Erector Spinae Plane Block with 0.2% ropivacaine with perineural 0.1mg/kg dexamethasne	Drug: perineural Dexamethasone; Erector Spinae Plane Block with 0.2% Ropivacaine + 0.1mg/kg perineural Dexamethasone
Active Comparator: intravenous dexamethasne; Erector Spinae Plane Block with 0.2% ropivacaine with intravenous 0.1mg/kg dexamethasne	Drug: intravenous Dexamethasone; Erector Spinae Plane Block with 0.2% Ropivacaine + 0.1mg/kg intravenous Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue opioid analgesia	Time to first rescue opioid analgesia	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NLR	Neutrophile-to-lymphocyte ratio	48 hours after surgery
NLR	Neutrophile-to-lymphocyte ratio	12 hours after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	12 hours after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	24 hours after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	48 hours after surgery
intraoperative requirement for propofol	intraoperative requirement for propofol in mg/kg	durring surgery
intraoperative requirement for remifentanil	intraoperative requirement for remifentanil in ug/kg	durring surgery
MEP	Motor evoced potentials durring surgery	durring surgery
Total opioid consumption	Total opioid consumption in milliequivalents of morphine per kg	48 after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	6 hours after surgery
NRS	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"	36 hours after surgery
PLR	Platelet-to-lymohocyte ratio	12 hours after surgery
PLR	Platelet-to-lymohocyte ratio	24 hours after surgery
PLR	Platelet-to-lymohocyte ratio	48 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: scoliosis; dexamethasone; erector spinae plane block; Neuromonitoring,
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Enzyme Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 1/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No