Poznan University of Medical Sciences
Poznan, 60-701, Poland
Location status: Recruiting
NCT Number: NCT06789029
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.
Interested in participating?
Request Info10 year–18 year
All sexes
Interventional
Phase 4
Poznan, 60-701, Poland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 48 hours after surgery
Time to first rescue opioid analgesia
Time frame: durring surgery
intraoperative requirement for propofol in mg/kg
Time frame: durring surgery
intraoperative requirement for remifentanil in ug/kg
Time frame: durring surgery
Motor evoced potentials durring surgery
Time frame: 48 after surgery
Total opioid consumption in milliequivalents of morphine per kg
Time frame: 6 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame: 12 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame: 24 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame: 36 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame: 48 hours after surgery
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame: 12 hours after surgery
Neutrophile-to-lymphocyte ratio
Time frame: 48 hours after surgery
Neutrophile-to-lymphocyte ratio
Time frame: 12 hours after surgery
Platelet-to-lymohocyte ratio
Time frame: 24 hours after surgery
Platelet-to-lymohocyte ratio
Time frame: 48 hours after surgery
Platelet-to-lymohocyte ratio
Contact information is provided by the study sponsor or research team.
Poznan University of Medical Sciences
Other
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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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