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Effect of perineurial dexamethasone and dexmedetomidine on popliteal nerve block duration for pediatric, ankle or foot 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 popliteal nerve block |
|
| Dexamethasone | Active Comparator | 0.2% ropivacaine + 0.1mg/kg Dexamethasone for popliteal nerve block |
|
| Dexmedetomidine | Active Comparator | 0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for popliteal nerve 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 popliteal nerve 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, MD PhD | Poznan University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Poznan | Poznań | 61-701 | Poland | ||
| Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41043950 | Derived | Reysner T, Pietraszek P, Shadi M, Musielak B, Kowalski G, Daroszewski P, Reysner M. Effect of perineural dexamethasone versus dexmedetomidine as adjuvants to ropivacaine on analgesic duration in pediatric popliteal sciatic nerve blocks: a randomized, triple-blinded, placebo-controlled trial. Reg Anesth Pain Med. 2025 Oct 2:rapm-2025-107096. doi: 10.1136/rapm-2025-107096. Online ahead of print. |
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| Dexamethasone | Drug | administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block |
|
|
| Dexmedetomidine | Drug | administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the popliteal nerve block |
|
| [Time Frame: 4 hours after surgery] |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | [Time Frame: 6 hours after surgery] |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | [Time Frame: 8 hours after surgery] |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | [Time Frame: 12 hours after surgery] |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | [Time Frame: 24 hours after surgery] |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | [Time Frame: 48 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 |
| Poznan |
| Wielkopolska |
| 61-545 |
| Poland |
| ID | Term |
|---|---|
| D018409 | Foot Injuries |
| D004194 | Disease |
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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