Dexmedetomidine Vs Dexamethasone in Popliteal Nerve Block
- Conditions
- Ankle DiseaseAnkle Injuries and DisordersFoot InjuryFoot Diseases
- Interventions
- Registration Number
- NCT06304324
- Lead Sponsor
- Poznan University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- children scheduled for foot/ankle surgery
- body weight > 5kg
- infection at the site of the regional blockade
- coagulation disorders
- immunodeficiency
- ASA= or >4
- steroid medication in regular use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Block 0.9% Sodium chloride 0.2% ropivacaine for popliteal nerve block Dexamethasone 0.1mg/kg Dexamethasone 0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block Dexmedetomidine 0.05ug/kg Dexmedetomidine 0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block
- Primary Outcome Measures
Name Time Method time to the first need of opiate following the procedure within 48 hours Time after surgery when the patient needs opiate for the first time
- Secondary Outcome Measures
Name Time Method Platelet-to-lymphocyte ratio 24 hours after surgery The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions.
Time to mobilization within 48 hours Time after surgery when the patient moves the toe for the first time
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale 48 hours The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Neutrophil-to-lymphocyte ratio 24 hours after surgery Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample.
Trial Locations
- Locations (1)
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
🇵🇱Poznań, Wielkopolska, Poland