Dexmedetomidine Vs Dexamethasone in Popliteal Nerve Block

Poznan University of Medical Sciences (PUMS)

Status and phase: Enrolling; Phase 4

Conditions: Foot Diseases; Ankle Disease; Foot Injury; Ankle Injuries and Disorders

Treatments: Drug: 0.1mg/kg Dexamethasone; Drug: 0.9% Sodium chloride; Drug: 0.05ug/kg Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06304324

18/2023

Details and patient eligibility

About

Effect of Perineural Dexmedetomidine vs. 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 popliteal block for analgesia after pediatric ankle surgery.

After ankle/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 anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics 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 perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.

The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.

Enrollment: 90 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children scheduled for foot/ankle 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: Quadruple Blind

---

90 participants in 3 patient groups, including a placebo group

Sham Block

Placebo Comparator group

Description:

0.2% ropivacaine for popliteal nerve block

Treatment:

Drug: 0.9% Sodium chloride

Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: 0.1mg/kg Dexamethasone

Dexmedetomidine

Active Comparator group

Description:

0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block

Treatment:

Drug: 0.05ug/kg Dexmedetomidine