Perineural 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 Injury; Ankle Injuries

Treatments: Drug: 0.9 % Sodium Chloride; Drug: 0.05mg/kg Dexamethasone; Drug: 0.1mg/kg Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06086418

13/2023

Details and patient eligibility

About

Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

0.2% ropivacaine for popliteal nerve block

Treatment:

Drug: 0.9 % Sodium Chloride

0.1mg/kg Dexamethasone

Active Comparator group

Description:

0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block

Treatment:

Drug: 0.1mg/kg Dexamethasone

0,05mg/kg dexamethasone

Active Comparator group

Description:

0.05mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block

Treatment:

Drug: 0.05mg/kg Dexamethasone