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Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.
This study is proposed to explore the effect of systemic Dexamethasone on the duration of popliteal block for analgesia after pediatric ankle surgery.
After ankle/foot 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 anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.
The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Block | Placebo Comparator | 0.2% ropivacaine for popliteal nerve block |
|
| Dexamethasone | Active Comparator | 0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block |
|
| Dexmedetomidine | Active Comparator | 0.5ug/kg dexmedetomidine added to 0.2% ropivacaine 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 |
|---|---|---|
| time to the first need of opiate following the procedure | Time after surgery when the patient needs opiate for the first time | within 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malgorzata Domagalska, PhD | Contact | 608762068 | m.domagalska@icloud.com | |
| Malgorzata Domalska, PhD | Contact | 608762068 |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Kotwicki, Prof dr hab | Poznan University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland | Recruiting | Poznan | Wielkopolska | 61-545 | Poland |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D004194 | Disease |
| D018409 | Foot Injuries |
| D005534 | Foot Diseases |
| 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 |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.1mg/kg Dexamethasone | Drug | administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block |
|
| 0.05ug/kg Dexmedetomidine | Drug | administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block |
|
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | 6 hours |
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | 8 hours |
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | 12 hours |
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | 16 hours |
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | 20 hours |
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | 24 hours |
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | 36 hours |
| Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale | The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. | 48 hours |
| Neutrophil-to-lymphocyte ratio | Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample. | 24 hours after surgery |
| Platelet-to-lymphocyte ratio | The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions. | 48 hours after surgery |
| Platelet-to-lymphocyte ratio | The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions. | 24 hours after surgery |
| Time to mobilization | Time after surgery when the patient moves the toe for the first time | within 48 hours |
| D009140 | Musculoskeletal Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| 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 |