Scoliosis Idiopathic, Scoliosis, Scoliosis; Adolescence
Conditions
Brief summary
Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
Detailed description
This study proposes to explore the effect of perineurial Dexmedetomidine on the duration of erector spinal plane block for pediatric idiopathic scoliosis surgery. Children need good analgesia after scoliosis surgery. 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 Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.
Interventions
DRUGDexmedetomidine
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block
DRUG0.9%NaCl
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane 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
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 opioid analgesia | 48 hours after surgery | Time after surgery when the patient needs opiate for the first time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 48 hours after surgery | Total opiate consumption after surgery |
| Numerical Rating Scale [range 0:10] | 4 hours after surgery | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) |
| 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 | durring surgery | nausea, vomitting, bradycardia, hypotension |
| MEP | durring surgery | motor evoced potentials |
Countries
Poland
Outcome results
None listed