Dexamethasone vs. Dexmedetomidine for Popliteal Nerve Block in Pain Management After Pediatric Ankle and Foot Surgery

Poznan University of Medical Sciences (PUMS)

Status and phase: Completed; Phase 4

Conditions: Foot Injuries and Disorders; Ankle Injuries and Disorders

Treatments: Drug: Dexamethasone; Drug: Dexmedetomidine; Drug: 0.9%sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06233565

1/2024

Details and patient eligibility

About

Effect of perineurial dexamethasone and dexmedetomidine on popliteal nerve block duration for pediatric, ankle or foot surgery

Full description

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

After scoliosis 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 or Dexmedetomidine, 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 and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic.

The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Enrollment: 90 patients

Sex: All

Ages: 3 months to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all children scheduled for ankle or foot surgery
• aged > 3 months < 7 years

Exclusion criteria

• age < 3 months
• age > 7 years
• infection at the site of the regional blockade
• coagulation disorders
• immunodeficiency
• ASA= or >4
• steroid medication in regular use
• chronic pain

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

Dexamethasone

Active Comparator group

Description:

0.2% ropivacaine + 0.1mg/kg Dexamethasone for popliteal nerve block

Treatment:

Drug: Dexamethasone

Dexmedetomidine

Active Comparator group

Description:

0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for popliteal nerve block

Treatment:

Drug: Dexmedetomidine