Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Phase 4

Completed

• Conditions: Ankle Injuries; Ankle Disease; Foot Injury; Foot Diseases
• Interventions: Drug: 0.9 % Sodium Chloride; Drug: 0.1mg/kg Dexamethasone; Drug: 0.05mg/kg Dexamethasone

• Registration Number: NCT06086418
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot 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 foot and ankle 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 perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic.

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: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study Start: 2023-10-17
• Study First Posted: 2023-10-17
• Primary Completion: 2024-02-23
• Study Completion: 2024-03-30
• Status Verified: 2024-04
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-21

Recruitment & Eligibility

• Status: COMPLETED
• 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
placebo	0.9 % Sodium Chloride	0.2% ropivacaine for popliteal nerve block
0.1mg/kg Dexamethasone	0.1mg/kg Dexamethasone	0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block
0,05mg/kg dexamethasone	0.05mg/kg Dexamethasone	0.05mg/kg dexamethasone added to 0.2% ropivacaine for 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
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)
Blood glucose	24 and 48 hours after surgery	Blood glucose every 24 hours during hospitalization
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	Toe movement every 4 hours

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poznań, Poland