Ankle Disease, Foot Deformities, Foot Diseases, Cerebral Palsy
Conditions
Brief summary
Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery
Detailed description
This study is proposed to explore the effect of systemic dexamethasone on the duration of popliteal nerve block for analgesia after pediatric ankle surgery. After ankle or 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 anesthesia is particularly important in children due to the much lower toxicity threshold of local anesthetics. The use of an effective adjuvant, such as Dexamethasone, could allow for the use of a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect. There is multiple research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a huge lack of research regarding children. In this study, investigators compare different doses of systemic dexamethasone. Before the anesthesia, the patients receive dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg, and 0.2mg/kg. The investigator's goal is to find a dexamethasone dose that is as low as possible but at the same time covers the need for good pain relief and fast recovery postoperatively.
Interventions
administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block
administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block
administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* children scheduled for ankle/foot 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 |
|---|---|---|
| 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) |
| Blood glucose | 24 and 48 hours after surgery | Blood glucose every 24 hour during hospitalization |
| Opioid Consumption | 48 hours | Total opiate consumption after surgery |
| PLR | 24 and 48 hours after surgery | Platelet-to-lymphocyte ratio |
| 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 |
| NLR | 24 and 48 hours after surgery | Neutrophil-to-lymphocyte ratio |
Countries
Poland
Outcome results
None listed