NCT06086418

Brief Summary

Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia 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

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

January 21, 2025

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

October 11, 2023

Last Update Submit

January 17, 2025

Conditions

Ankle DiseaseAnkle InjuriesFoot InjuryFoot Diseases

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

PLACEBO COMPARATOR

0.2% ropivacaine for popliteal nerve block

Drug: 0.9 % Sodium Chloride

0.1mg/kg Dexamethasone

ACTIVE COMPARATOR

0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block

Drug: 0.1mg/kg Dexamethasone

0,05mg/kg dexamethasone

ACTIVE COMPARATOR

0.05mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block

Drug: 0.05mg/kg Dexamethasone

Interventions

0.9 % Sodium ChlorideDRUG

administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block

Also known as: placebo
placebo
0.1mg/kg DexamethasoneDRUG

administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block

Also known as: large dose
0.1mg/kg Dexamethasone
0.05mg/kg DexamethasoneDRUG

administration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone for the popliteal nerve block

Also known as: small dose
0,05mg/kg dexamethasone

Eligibility Criteria

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

You may qualify if:

  • children scheduled for hand/wrist 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 (1)

Poznan University of Medical Sciences

Poznan, Poznań, 61-701, Poland

Location

Related Publications (1)

  • Reysner M, Reysner T, Janusz P, Kowalski G, Shadi M, Daroszewski P, Wieczorowska-Tobis K, Kotwicki T. Dexamethasone as a perineural adjuvant to a ropivacaine popliteal sciatic nerve block for pediatric foot surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2025 Dec 5;50(12):970-976. doi: 10.1136/rapm-2024-105694.

    PMID: 39209730DERIVED

MeSH Terms

Conditions

Ankle InjuriesFoot InjuriesFoot Diseases

Interventions

Sodium ChlorideDexamethasone

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesMusculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Tomasz Kotwicki, Prof.dr hab.

    Poznan University of Medical Sciences

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

October 17, 2023

Primary Completion

February 23, 2024

Study Completion

March 30, 2024

Last Updated

January 21, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)