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

Phase 4

Recruiting

• Conditions: Wrist Disease; Hand Injuries and Disorders
• Interventions: Drug: 0,1mg/kg Dexamethasone; Drug: 0,2mg/kg Dexamethasone; Drug: Sodium Chloride 0.9% Inj

• Registration Number: NCT05887778
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Study Start: 2023-09-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0,1mg/kg Dexamethasone	0,1mg/kg Dexamethasone	0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
0,2 mg/kg Dexamethasone	0,2mg/kg Dexamethasone	0,2 mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
placebo injection	Sodium Chloride 0.9% Inj	5ml of 0,9% sodium chloride - before the popliteal nerve block

Primary Outcome Measures

Name	Time	Method
first need of opiate	48 hours	Time after surgery when the patient needs opiate for the first time

Secondary Outcome Measures

Name	Time	Method
Blood glucose	24 and 48 hours after surgery	Blood glucose every 24 hour during hospitalization
Opioid Consumption	48 hours	Total opiate consumption after surgery
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	children \<3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children \>3years old NRS (Numerical Rating Scale)
NLR	24 and 48 hours after surgery	Neutrophil-to-lymphocyte ratio
PLR	24 and 48 hours after surgery	Platelet-to-lymphocyte ratio
Mobilisation	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	Finger movement every 4 hours

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland