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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 61-545
      • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
    • Poznan, Wielkopolska, Poland, 61-701
      • Poznan Univesity of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: placebo injection; 5ml of 0,9% sodium chloride - before the popliteal nerve block	Drug: Sodium Chloride 0.9% Inj; administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block; Other Names: Placebo
Active Comparator: 0,1mg/kg Dexamethasone; 0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block	Drug: 0,1mg/kg Dexamethasone; administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block; Other Names: small dose
Active Comparator: 0,2mg/kg Dexamethasone; 0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block	Drug: 0,2mg/kg Dexamethasone; administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block; Other Names: large dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Tomasz Kotwicki, Prof.dr hab., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): July 29, 2025

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Brain Damage, Chronic; Skin and Connective Tissue Diseases; Cerebral Palsy; Foot Diseases; Foot Deformities; Substandard Drugs; Pharmaceutical Preparations; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Counterfeit Drugs; Sodium Chloride
• Other Study ID Numbers: 8/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No