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

Phase 4

Recruiting

• Conditions: Ankle Injuries and Disorders; Foot Injuries and Disorders
• Interventions: Drug: 0.9%sodium chloride; Drug: Dexamethasone; Drug: Dexmedetomidine

• Registration Number: NCT06233565
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Study Start: 2024-02-09
• Status Verified: 2024-04
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-21
• Primary Completion: 2025-02-15
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	0.9%sodium chloride	0.2% ropivacaine for popliteal nerve block
Dexamethasone	Dexamethasone	0.2% ropivacaine + 0.1mg/kg Dexamethasone for popliteal nerve block
Dexmedetomidine	Dexmedetomidine	0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for popliteal nerve block

Primary Outcome Measures

Name	Time	Method
first need of opiate	48 hours	Time after surgery when the patient needs opiate for the first time

Secondary Outcome Measures

Name	Time	Method
PLR	24 and 48 hours after surgery	Platelet-to-lymphocyte ratio
Numerical Rating Scale [range 0:10]	[Time Frame: 48 hours after surgery]	NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
NLR	24 and 48 hours after surgery	Neutrophil-to-lymphocyte ratio
Opioid consumption	48 hours	Total opiate consumption after surgery

Trial Locations

Locations (2)

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland; 🇵🇱 Poznań, Wielkopolska, Poland

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poznań, Poland