Clinical trial NCT06304324: Dexmedetomidine Vs Dexamethasone in Popliteal Nerve Block
Official title: Perineural Dexmedetomidine Vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ankle Disease
Ankle Injuries and Disorders
Foot Injury
Foot Diseases
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: time to the first need of opiate following the procedure
timeFrame: within 48 hours
Secondary outcomes:
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
timeFrame: 4 hours
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
timeFrame: 6 hours
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
timeFrame: 8 hours
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
timeFrame: 12 hours
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
timeFrame: 16 hours
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
timeFrame: 20 hours
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
timeFrame: 24 hours
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
timeFrame: 36 hours
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
timeFrame: 48 hours
measure: Neutrophil-to-lymphocyte ratio
timeFrame: 24 hours after surgery
measure: Platelet-to-lymphocyte ratio
timeFrame: 48 hours after surgery
measure: Platelet-to-lymphocyte ratio
timeFrame: 24 hours after surgery
measure: Time to mobilization
timeFrame: within 48 hours
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
state: Wielkopolska
Study officials:
affiliation: Poznan University of Medical Sciences
name: Tomasz Kotwicki, Prof dr hab
role: STUDY_CHAIR
References: