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ScoliosisPhase 4NCT06616220

Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

A Phase 4 study testing Dexamethasone and 0.9%NaCl in people with Scoliosis and Scoliosis Idiopathic, run by Poznan University of Medical Sciences at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Effect of perineurial dexamethasone on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery. Read more about this study

Who is it for?
Ages 10 to 18 years
What is being tested?
Dexamethasone and 0.9%NaCl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 sitePoland
Study dates
1 Oct 2024to 7 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

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

  • children scheduled for idiopathic scoliosis surgery
  • age >10 and <18 years

Who cannot join

  • age < 10 years
  • age < 18 years
  • infection at the site of the regional blockade
  • coagulation disorders
  • immunodeficiency
  • ASA= or >4
  • steroid medication in regular use

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

    Poznan, Wielkopolska, 61-545

Other trials in Poland

About this study

Official title: Dexamethasone for ESPB in Pain Management After Pediatric Idiopathic

Effect of perineurial dexamethasone on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

Read the detailed description

This study proposes to explore the effect of perineurial Dexamethasone on erector spinal plane block duration for pediatric idiopathic scoliosis surgery.

Children need good analgesia after scoliosis surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

Being tested
Dexamethasone, 0.9%NaCl
Medical subject headings
Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called Dexaethasone

    administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block

  • 0.9%NaClDrug

    Also called administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block

    0.9% NaCl

Study groups in NCT06616220
Study groupRoleWhat they receive
DEXAMETHASONEActive comparator0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block
Receives: Drug: Dexamethasone
CONTROLPlacebo comparator0.2% ropivacaine for erector spinae plane block
Receives: Drug: 0.9%NaCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First need of opioid analgesia

    Time after surgery when the patient needs opiate for the first time

    Measured: 48 hours after surgery

Secondary outcomes (13)

  1. Opioid consumption

    Total opiate consumption after surgery

    Measured: 48 hours after procedure

  2. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Measured: 4 hours after surgery

  3. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Measured: 8 hours after surgery

  4. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Measured: 12 hours after surgery

  5. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Measured: 24 hours after surgery

  6. Numerical Rating Scale [range 0:10]

    NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)

    Measured: 48 hours after surgery

  7. Nerve damage [range 0-4]

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

    Measured: 12 hours after surgery

  8. Nerve damage [range 0-4]

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

    Measured: 24 hours after surgery

  9. Nerve damage [range 0-4]

    Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)

    Measured: 48 hours after surgery

  10. glucose

    blood glucose level

    Measured: 12 hours after surgery

  11. glucose

    blood glucose level

    Measured: 24 hours after surgery

  12. glucose

    blood glucose level

    Measured: 48 hours after surgery

  13. MEP

    Motor-Evoced-Potentials

    Measured: durring surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start1 Oct 2024
  3. Primary completion7 Oct 2025
  4. Study completion7 Oct 2025

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06616220
Sponsor's protocol ID
11/2024
Status last verified
Oct 2025
First submitted
24 Sep 2024
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone and 0.9%NaCl in people with Scoliosis and Scoliosis Idiopathic, run by Poznan University of Medical Sciences at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First need of opioid analgesia (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06616220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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