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

Poznan University of Medical Sciences (PUMS)

Status and phase: Enrolling; Phase 4

Conditions: Wrist Disease; Hand Injuries and Disorders

Treatments: Drug: 0,2mg/kg Dexamethasone; Drug: Sodium Chloride 0.9% Inj; Drug: 0,1mg/kg Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05887778

9/2023

Details and patient eligibility

About

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

Full description

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

placebo injection

Active Comparator group

Description:

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

Treatment:

Drug: Sodium Chloride 0.9% Inj

0,1mg/kg Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: 0,1mg/kg Dexamethasone

0,2 mg/kg Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: 0,2mg/kg Dexamethasone