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Ankle DiseasePhase 4NCT05887765

Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

A Phase 4 study testing Sodium Chloride 0.9% Inj, 0,1mg/kg Dexamethasone and 0,2mg/kg Dexamethasone in people with Ankle Disease and Foot Deformities, run by Poznan University of Medical Sciences at 2 sites 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 systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery Read more about this study

Who is it for?
Ages 3 months to 18 yearsHealthy volunteers can take part
Conditions the study is for
Ankle Disease, Foot Deformities, Foot Diseases
What is being tested?
Sodium Chloride 0.9% Inj, 0,1mg/kg Dexamethasone and 0,2mg/kg Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesPoland
Study dates
17 Oct 2023to 29 Jul 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 3 months to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • children scheduled for ankle/foot surgery
  • body weight > 5kg

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Poland2 sites

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

    Poznan, Wielkopolska, 61-545

  • Poznan Univesity of Medical Sciences

    Poznan, Wielkopolska, 61-701

Other trials in Poland

About this study

Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery

Read the detailed description

This study is proposed to explore the effect of systemic dexamethasone on the duration of popliteal nerve block for analgesia after pediatric ankle surgery.

After ankle or foot surgery, children need good analgesia. 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 particularly important in children due to the much lower toxicity threshold of local anesthetics. The use of an effective adjuvant, such as Dexamethasone, could allow for the use of a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is multiple research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a huge lack of research regarding children.

In this study, investigators compare different doses of systemic dexamethasone. Before the anesthesia, the patients receive dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg, and 0.2mg/kg.

The investigator's goal is to find a dexamethasone dose that is as low as possible but at the same time covers the need for good pain relief and fast recovery postoperatively.

Being tested
Sodium Chloride 0.9% Inj, 0,1mg/kg Dexamethasone, 0,2mg/kg Dexamethasone
Medical subject headings
Foot Deformities, Foot Diseases, Cerebral Palsy

What participants receive

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

  • Sodium Chloride 0.9% InjDrug

    Also called Placebo

    administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block

  • 0,1mg/kg DexamethasoneDrug

    Also called small dose

    administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

  • 0,2mg/kg DexamethasoneDrug

    Also called large dose

    administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

Study groups in NCT05887765
Study groupRoleWhat they receive
placebo injectionActive comparator5ml of 0,9% sodium chloride - before the popliteal nerve block
Receives: Drug: Sodium Chloride 0.9% Inj
0,1mg/kg DexamethasoneActive comparator0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
Receives: Drug: 0,1mg/kg Dexamethasone
0,2mg/kg DexamethasoneActive comparator0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
Receives: Drug: 0,2mg/kg Dexamethasone

What is being measured

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

  1. first need of opiate

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

    Measured: 48 hours

Secondary outcomes (6)

  1. Opioid Consumption

    Total opiate consumption after surgery

    Measured: 48 hours

  2. Pain score

    children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)

    Measured: 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery

  3. Blood glucose

    Blood glucose every 24 hour during hospitalization

    Measured: 24 and 48 hours after surgery

  4. NLR

    Neutrophil-to-lymphocyte ratio

    Measured: 24 and 48 hours after surgery

  5. PLR

    Platelet-to-lymphocyte ratio

    Measured: 24 and 48 hours after surgery

  6. Mobilisation

    Toe movement every 4 hours

    Measured: 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 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.

  1. First posted5 Jun 2023
  2. Study start17 Oct 2023
  3. Primary completion30 Jun 2025
  4. Study completion29 Jul 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887765
Sponsor's protocol ID
8/2023
Status last verified
Sep 2025
First submitted
24 May 2023
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Reysner T, Ciftci B, Pietraszek P, Purat T, Shadi M, Musielak B, Idzior M, Daroszewski P, Reysner M. Effect of intravenous dexamethasone on duration of analgesia following popliteal nerve block in pediatric ankle surgery: A randomized, triple-blinded clinical trial. J Clin Anesth. 2026 Feb;109:112094. doi: 10.1016/j.jclinane.2025.112094. Epub 2025 Dec 5.

    PubMed 41352236

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sodium Chloride 0.9% Inj, 0,1mg/kg Dexamethasone and 0,2mg/kg Dexamethasone in people with Ankle Disease and Foot Deformities, run by Poznan University of Medical Sciences at 2 sites 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 5 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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 opiate (time frame: 48 hours). 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 NCT05887765, which also lists 1 linked publication.

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 18 Sep 2025.

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