NCT06086392

Brief Summary

Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist 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

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
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2025

Completed
Last Updated

July 23, 2025

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

October 11, 2023

Last Update Submit

July 19, 2025

Conditions

Wrist DiseaseHand InjuriesWrist InjuriesHand DiseaseHand Injuries and Disorders

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

ACTIVE COMPARATOR

0.2% ropivacaine for supraclavicular brachial plexus block

Drug: Placebo

0.1mg/kg Dexamethasone

ACTIVE COMPARATOR

0,1mg/kg dexamethasone added to 0.2% ropivacaine for supraclavicular brachial plexus block

Drug: 0.1mg/kg Dexamethasone

0,05mg/kg dexamethasone

ACTIVE COMPARATOR

0,05mg/kg dexamethasone added to 0.2% ropivacaine for supraclavicular brachial plexus block

Drug: 0.05mg/kg Dexamethasone

Interventions

PlaceboDRUG

administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the supraclavicular brachial plexus block

Also known as: 0.9% sodium chloride
Placebo
0.1mg/kg DexamethasoneDRUG

administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the supraclavicular brachial plexus block

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

administration of 0.5ml/kg of 0,2% ropivacaine with 0.05mg/kg Dexamethasone for the supraclavicular brachial plexus block

Also known as: small dose dexamethasone
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

Skórzewo, Poznań, 61-701, Poland

Location

MeSH Terms

Conditions

Hand InjuriesWrist InjuriesDisease

Interventions

Sodium ChlorideDexamethasone

Condition Hierarchy (Ancestors)

Wounds and InjuriesArm InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Leszek Romanowski, 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

June 30, 2025

Study Completion

July 11, 2025

Last Updated

July 23, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)