Ankle Disease, Ankle Injuries, Foot Injury, Foot Diseases
Conditions
Brief summary
Effect of Perineural 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 supraclavicular brachial plexus block for analgesia after pediatric ankle surgery. After foot and ankle 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, 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 use has been compared in adults. However, there is a massive lack of research regarding children. In this study, investigators compare different doses of perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic. The investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously covers the need for good pain relief and fast recovery postoperatively.
Interventions
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
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone for the popliteal nerve block
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* children scheduled for hand/wrist 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 |
|---|---|---|
| first need of opiate | 48 hours | Time after surgery when the patient needs opiate for the first time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobilisation | 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery | Toe movement every 4 hours |
| Opioid Consumption | 48 hours | Total opiate consumption after surgery |
| PLR | 24 and 48 hours after surgery | Platelet-to-lymphocyte ratio |
| Blood glucose | 24 and 48 hours after surgery | Blood glucose every 24 hours during hospitalization |
| NLR | 24 and 48 hours after surgery | Neutrophil-to-lymphocyte ratio |
| Pain score | 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery | children \<3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children \>3years old NRS (Numerical Rating Scale) |
Countries
Poland
Outcome results
None listed