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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age10-18
SponsorPoznan University of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>10 and <18 years old

scheduled for idiopathic scoliosis surgery

Disqualifiers

included infection at the site of the regional block,

coagulation disorders,

immunodeficiency,

American Society of Anesthesiologists (ASA) physical status of IV or higher,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: perineural DexamethasoneActive comparator 1 intervention
Group B: intravenous dexamethasneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to first rescue opioid analgesia

Time to first rescue opioid analgesia

Time frame
48 hours after surgery

Secondary outcomes

1

intraoperative requirement for propofol

intraoperative requirement for propofol in mg/kg

Time frame
durring surgery
2

intraoperative requirement for remifentanil

intraoperative requirement for remifentanil in ug/kg

Time frame
durring surgery
3

MEP

Motor evoced potentials durring surgery

Time frame
durring surgery
4

Total opioid consumption

Total opioid consumption in milliequivalents of morphine per kg

Time frame
48 after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.