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

NCT ID: NCT05887765

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2025-07-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Ankle Disease Foot Deformities Foot Diseases Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo injection

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

Group Type ACTIVE_COMPARATOR

Sodium Chloride 0.9% Inj

Intervention Type DRUG

administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block

0,1mg/kg Dexamethasone

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

Group Type ACTIVE_COMPARATOR

0,1mg/kg Dexamethasone

Intervention Type DRUG

administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

0,2mg/kg Dexamethasone

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

Group Type ACTIVE_COMPARATOR

0,2mg/kg Dexamethasone

Intervention Type DRUG

administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

Interventions

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Sodium Chloride 0.9% Inj

administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block

Intervention Type DRUG

0,1mg/kg Dexamethasone

administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

Intervention Type DRUG

0,2mg/kg Dexamethasone

administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

Intervention Type DRUG

Other Intervention Names

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Placebo small dose large dose

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomasz Kotwicki, Prof.dr hab.

Role: STUDY_CHAIR

Poznań University of Medical Sciences

Locations

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Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

Poznan, Wielkopolska, Poland

Site Status

Poznan Univesity of Medical Sciences

Poznan, Wielkopolska, Poland

Site Status

Countries

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Poland

Other Identifiers

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8/2023

Identifier Type: -

Identifier Source: org_study_id

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