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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06789029
Enrollment
60
Registered
2025-01-23
Start date
2025-02-01
Completion date
2026-01-31
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis Idiopathic Adolescent

Keywords

scoliosis, Neuromonitoring,, erector spinae plane block, dexamethasone

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.

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.

Interventions

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

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

Sponsors

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to first rescue opioid analgesia48 hours after surgeryTime to first rescue opioid analgesia

Secondary

MeasureTime frameDescription
intraoperative requirement for propofoldurring surgeryintraoperative requirement for propofol in mg/kg
intraoperative requirement for remifentanildurring surgeryintraoperative requirement for remifentanil in ug/kg
MEPdurring surgeryMotor evoced potentials durring surgery
PLR12 hours after surgeryPlatelet-to-lymohocyte ratio
NRS6 hours after surgeryThe numeric rating scale (NRS) with zero meaning no pain and 10 meaning the worst pain imaginable
NLR12 hours after surgeryNeutrophile-to-lymphocyte ratio
Total opioid consumption48 after surgeryTotal opioid consumption in milliequivalents of morphine per kg

Countries

Poland

Contacts

Primary ContactMalgorzata Reysner, M.D. Ph.D.
mdomagalska@ump.edu.pl+48608762068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026