Ankle Disease, Ankle Injuries and Disorders, Foot Injury, Foot Diseases
Conditions
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.
Interventions
DRUG0.9% Sodium chloride
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
DRUG0.05ug/kg Dexmedetomidine
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | 4 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. |
| Platelet-to-lymphocyte ratio | 48 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 |
Countries
Poland
Contacts
Primary ContactMalgorzata Domagalska, PhD
Backup ContactMalgorzata Domalska, PhD
Outcome results
None listed