Foot Injuries and Disorders, Ankle Injuries and Disorders
Conditions
Brief summary
Effect of perineurial dexamethasone and dexmedetomidine on popliteal nerve block duration for pediatric, ankle or foot surgery
Detailed description
This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery. After scoliosis 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 or Dexmedetomidine, 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 and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children. In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic. The investigator aims to find a dexamethasone or dexmedetomidine that 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
DRUGDexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
DRUGDexmedetomidine
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine 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 7 Years
Healthy volunteers
No
Inclusion criteria
* all children scheduled for ankle or foot surgery * aged \> 3 months \< 7 years
Exclusion criteria
* age \< 3 months * age \> 7 years * infection at the site of the regional blockade * coagulation disorders * immunodeficiency * ASA= or \>4 * steroid medication in regular use * chronic pain
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 |
|---|---|---|
| Opioid consumption | 48 hours | Total opiate consumption after surgery |
| Numerical Rating Scale [range 0:10] | [Time Frame: 4 hours after surgery] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) |
| NLR | 24 and 48 hours after surgery | Neutrophil-to-lymphocyte ratio |
| PLR | 24 and 48 hours after surgery | Platelet-to-lymphocyte ratio |
Countries
Poland
Outcome results
None listed