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

Poznan University of Medical Sciences (PUMS)

Status and phase: Completed; Phase 4

Conditions: Foot Diseases; Ankle Disease; Foot Deformities; Cerebral Palsy

Treatments: Drug: Sodium Chloride 0.9% Inj; Drug: 0,2mg/kg Dexamethasone; Drug: 0,1mg/kg Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05887765

8/2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

placebo injection

Active Comparator group

Description:

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

Treatment:

Drug: Sodium Chloride 0.9% Inj

0,1mg/kg Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: 0,1mg/kg Dexamethasone

0,2mg/kg Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: 0,2mg/kg Dexamethasone