Scoliosis Idiopathic AdolescentPhase 4NCT06789029
The Effect of Dexamethasone Administration Route and Local Anesthetic Concentration on Pain, Inflammatory Response, and Neuromonitoring in Children Undergoing Scoliosis Correction
A Phase 4 study testing perineural Dexamethasone and intravenous Dexamethasone in people with Scoliosis Idiopathic Adolescent, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent
- What is being tested?
- perineural Dexamethasone and intravenous Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2025to 30 Sep 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- >10 and <18 years old
- scheduled for idiopathic scoliosis surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Scoliosis Idiopathic Adolescent
- Being tested
- perineural Dexamethasone, intravenous Dexamethasone
- Keywords
- scoliosis, Neuromonitoring,, erector spinae plane block, dexamethasone
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineural DexamethasoneDrug
Erector Spinae Plane Block with 0.2% Ropivacaine + 0.1mg/kg perineural Dexamethasone
intravenous DexamethasoneDrug
Erector Spinae Plane Block with 0.2% Ropivacaine + 0.1mg/kg intravenous Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| perineural Dexamethasone | Active comparator | Erector Spinae Plane Block with 0.2% ropivacaine with perineural 0.1mg/kg dexamethasne Receives: Drug: perineural Dexamethasone |
| intravenous dexamethasne | Active comparator | Erector Spinae Plane Block with 0.2% ropivacaine with intravenous 0.1mg/kg dexamethasne Receives: Drug: intravenous Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue opioid analgesia
Time to first rescue opioid analgesia
Measured: 48 hours after surgery
Secondary outcomes (14)
intraoperative requirement for propofol
intraoperative requirement for propofol in mg/kg
Measured: durring surgery
intraoperative requirement for remifentanil
intraoperative requirement for remifentanil in ug/kg
Measured: durring surgery
MEP
Motor evoced potentials durring surgery
Measured: durring surgery
Total opioid consumption
Total opioid consumption in milliequivalents of morphine per kg
Measured: 48 after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 6 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 12 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 24 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 36 hours after surgery
NRS
The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 48 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Measured: 12 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Measured: 48 hours after surgery
PLR
Platelet-to-lymohocyte ratio
Measured: 12 hours after surgery
PLR
Platelet-to-lymohocyte ratio
Measured: 24 hours after surgery
PLR
Platelet-to-lymohocyte ratio
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Feb 2025
- Primary completion23 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789029
- Sponsor's protocol ID
- 1/2025
- Status last verified
- May 2026
- First submitted
- 17 Jan 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes