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NCT Number: NCT06789029

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Poznan University of Medical Sciences

Poznan, 60-701, Poland

Location status: Recruiting

Location contact

Malgorzata Reysner, M.D. Ph.D.

CONTACT

[email protected]

+48 608762068

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perineural dexamethasone

Drug

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

intravenous dexamethasone

Drug

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

Primary outcomes

  1. Time to first rescue opioid analgesia

    Time frame: 48 hours after surgery

    Time to first rescue opioid analgesia

Secondary outcomes

  1. intraoperative requirement for propofol

    Time frame: durring surgery

    intraoperative requirement for propofol in mg/kg

  2. intraoperative requirement for remifentanil

    Time frame: durring surgery

    intraoperative requirement for remifentanil in ug/kg

  3. MEP

    Time frame: durring surgery

    Motor evoced potentials durring surgery

  4. Total opioid consumption

    Time frame: 48 after surgery

    Total opioid consumption in milliequivalents of morphine per kg

  5. NRS

    Time frame: 6 hours after surgery

    The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  6. NRS

    Time frame: 12 hours after surgery

    The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  7. NRS

    Time frame: 24 hours after surgery

    The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  8. NRS

    Time frame: 36 hours after surgery

    The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  9. NRS

    Time frame: 48 hours after surgery

    The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

  10. NLR

    Time frame: 12 hours after surgery

    Neutrophile-to-lymphocyte ratio

  11. NLR

    Time frame: 48 hours after surgery

    Neutrophile-to-lymphocyte ratio

  12. PLR

    Time frame: 12 hours after surgery

    Platelet-to-lymohocyte ratio

  13. PLR

    Time frame: 24 hours after surgery

    Platelet-to-lymohocyte ratio

  14. PLR

    Time frame: 48 hours after surgery

    Platelet-to-lymohocyte ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Malgorzata Reysner, M.D. Ph.D.

CONTACT

[email protected]

+48608762068

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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