NCT05887778

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

September 18, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

May 24, 2023

Last Update Submit

October 11, 2023

Conditions

Wrist 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 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

0,2 mg/kg Dexamethasone

ACTIVE COMPARATOR

0,2 mg/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 supraclavicular brachial plexus block

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

administration of 0,1mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block

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

administration of 0,2mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block

Also known as: large dose
0,2 mg/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, Poland

RECRUITING

MeSH Terms

Conditions

Hand InjuriesDisease

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Leszek Romanowski, Prof.dr hab

    Poznań University of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Małgorzata Domagalska

CONTACT

608762068m.domagalska@icloud.com

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

September 18, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations

PL(1)