NCT05887765

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

May 24, 2023

Last Update Submit

September 12, 2025

Conditions

Ankle DiseaseFoot DeformitiesFoot DiseasesCerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • first need of opiate

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

    48 hours

Secondary Outcomes (6)

  • Opioid Consumption

    48 hours

  • Pain score

    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

  • Blood glucose

    24 and 48 hours after surgery

  • NLR

    24 and 48 hours after surgery

  • PLR

    24 and 48 hours after surgery

  • +1 more secondary outcomes

Study Arms (3)

placebo injection

ACTIVE COMPARATOR

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

Drug: Sodium Chloride 0.9% Inj

0,1mg/kg Dexamethasone

ACTIVE COMPARATOR

0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block

Drug: 0,1mg/kg Dexamethasone

0,2mg/kg Dexamethasone

ACTIVE COMPARATOR

0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block

Drug: 0,2mg/kg Dexamethasone

Interventions

Sodium Chloride 0.9% InjDRUG

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

Also known as: Placebo
placebo injection
0,1mg/kg DexamethasoneDRUG

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

Also known as: small dose
0,1mg/kg Dexamethasone
0,2mg/kg DexamethasoneDRUG

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

Also known as: large dose
0,2mg/kg Dexamethasone

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Poznan, Wielkopolska, 61-545, Poland

Location

Poznan Univesity of Medical Sciences

Poznan, Wielkopolska, 61-701, Poland

Location

Related Publications (1)

  • 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.

    PMID: 41352236DERIVED

MeSH Terms

Conditions

Foot DeformitiesFoot DiseasesCerebral Palsy

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Tomasz Kotwicki, Prof.dr hab.

    Poznań University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 5, 2023

Study Start

October 17, 2023

Primary Completion

June 30, 2025

Study Completion

July 29, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

PL(2)