Scoliosis; Adolescence, Scoliosis Idiopathic
Conditions
Brief summary
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis 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
DRUG0.9% sodium chloride
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block
DRUGDexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block
DRUGDexmedetomidine
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane 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
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* children scheduled for idiopathic scoliosis surgery * age \>10 and \<18 years
Exclusion criteria
* age \< 10 years * age \< 18 years * 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 |
|---|---|---|
| Numerical Rating Scale [range 0:10] | 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 |
| Opioid consumption | 48 hours | Total opiate consumption after surgery |
| Nerve damage [range 0-4] | 12 hours after surgery | Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome) |
| adverce effects | 48 hours after surgery | nausea, vomitting, bradycardia, hypotension |
| MEP | durring surgery | motor evoced potentials |
Countries
Poland
Outcome results
None listed