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Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0.2% ropivacaine for erector spinae plane block |
|
| Dexamethasone | Active Comparator | 0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block |
|
| Dexmedetomidine | Active Comparator | 0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% sodium chloride | Drug | administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block |
|
| Measure | Description | Time Frame |
|---|---|---|
| first need of opiate | Time after surgery when the patient needs opiate for the first time | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Total opiate consumption after surgery | 48 hours |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Kotwicki, Prof.dr hab. | Poznan University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland | Poznan | Wielkopolska | 61-545 | Poland |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D003907 | Dexamethasone |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Dexamethasone | Drug | administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block |
|
| Dexmedetomidine | Drug | administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane block |
|
| 4 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 8 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 12 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 16 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 20 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 24 hours after surgery |
| NLR | Neutrophil-to-lymphocyte ratio | 24 and 48 hours after surgery |
| PLR | Platelet-to-lymphocyte ratio | 24 and 48 hours after surgery] |
| MEP | motor evoced potentials | durring surgery |
| Nerve damage [range 0-4] | 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) | 12 hours after surgery |
| Nerve damage [range 0-4] | 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) | 24 hours after surgery |
| Nerve damage [range 0-4] | 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) | 48 hours after surgery |
| adverce effects | nausea, vomitting, bradycardia, hypotension | 48 hours after surgery |
| D017670 |
| Sodium Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |