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

Phase 4

Completed

• Conditions: Ankle Disease; Foot Deformities; Foot Diseases; Cerebral Palsy
• Interventions: Drug: Sodium Chloride 0.9% Inj; Drug: 0,1mg/kg Dexamethasone; Drug: 0,2mg/kg Dexamethasone

• Registration Number: NCT05887765
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery

Detailed Description

This study is proposed to explore the effect of systemic dexamethasone on the duration of popliteal nerve block for analgesia after pediatric ankle surgery.

After ankle or foot 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 particularly important in children due to the much lower toxicity threshold of local anesthetics. The use of an effective adjuvant, such as Dexamethasone, could allow for the use of a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is multiple research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a huge 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 at the same time 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: 2023-10-17
• Status Verified: 2024-02
• Primary Completion: 2024-02-23
• Study Completion: 2024-02-23
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

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

Inclusion Criteria

• children scheduled for ankle/foot 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 injection	Sodium Chloride 0.9% Inj	5ml of 0,9% sodium chloride - before the popliteal nerve block
0,1mg/kg Dexamethasone	0,1mg/kg Dexamethasone	0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
0,2mg/kg Dexamethasone	0,2mg/kg Dexamethasone	0,2mg/kg dexamethasone sodium phosphate - 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
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 hour 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 (2)

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland; 🇵🇱 Poznań, Wielkopolska, Poland

Poznan Univesity of Medical Sciences; 🇵🇱 Poznań, Wielkopolska, Poland