Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

NCT ID: NCT05887778

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is proposed to explore the effect of systemic Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.

After hand and wrist 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 essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive 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 simultaneously covers the need for good pain relief and fast recovery postoperatively.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wrist Disease Hand Injuries and Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo injection

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

Group Type ACTIVE_COMPARATOR

Sodium Chloride 0.9% Inj

Intervention Type DRUG

administration of 5ml 0,9% sodium chloride - 30 minutes before the supraclavicular brachial plexus block

0,1mg/kg Dexamethasone

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

Group Type ACTIVE_COMPARATOR

0,1mg/kg Dexamethasone

Intervention Type DRUG

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

0,2 mg/kg Dexamethasone

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

Group Type ACTIVE_COMPARATOR

0,2mg/kg Dexamethasone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium Chloride 0.9% Inj

administration of 5ml 0,9% sodium chloride - 30 minutes before the supraclavicular brachial plexus block

Intervention Type DRUG

0,1mg/kg Dexamethasone

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

Intervention Type DRUG

0,2mg/kg Dexamethasone

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

placebo small dose large dose

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* children scheduled for hand/wrist surgery
* body weight \> 5kg

Exclusion Criteria

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

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Leszek Romanowski, Prof.dr hab

Role: STUDY_DIRECTOR

Poznań University of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Małgorzata Domagalska

Role: CONTACT

608762068

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

MAłgorzata Domagalska, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Paravertebral Nerve Blocks in Neonates
NCT03408340 TERMINATED PHASE4