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

NCT ID: NCT06789029

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Scoliosis Idiopathic Adolescent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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perineural Dexamethasone

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

Group Type ACTIVE_COMPARATOR

perineural Dexamethasone

Intervention Type DRUG

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

intravenous dexamethasne

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

Group Type ACTIVE_COMPARATOR

intravenous Dexamethasone

Intervention Type DRUG

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

Interventions

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perineural Dexamethasone

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

Intervention Type DRUG

intravenous Dexamethasone

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Malgorzata Reysner, M.D. Ph.D.

Role: CONTACT

+48608762068

Facility Contacts

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Malgorzata Reysner, M.D. Ph.D.

Role: primary

+48 608762068

Other Identifiers

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1/2025

Identifier Type: -

Identifier Source: org_study_id

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